Two mangoes in 1979

Evaluation report Palfium treatment

for long-term heroin addicts

G. H. A. van Brussel
M. C. A. Buster
D. H. van der Woude

Municipal Health Service Amsterdam

Contents

Contact: Municipal Health Service Amsterdam, G.H.A. van Brussel, MD, Tel (#31)(0)20 555 5232 or MAIL

Two mangoes in 1979
1. Foreword
2. Summary and conclusions
3. Objective
4. Target group/Admittance criteria and admittance thesis
5. The treatment
6. Data-collection method and project organization
6.1 Introduction
6.2 Data-collection method
6.3 Urine tests
6.4 Regular medical checks
7. Treatment progress
7.1 The client group
7.2 Client intake during the trial
7.3 Reasons for ending the palfium treatment
8. Morbidity/mortality
9. Social circumstances
9.1 Incomes
9.2 Housing
9.3 Lifestyle
9.4 Relationships and social contacts
9.5 Imprisonment
9.6 The social situation of palfium clients: a subjective impression
10. The individual subjective effects of palfium
10.1 Intoxicating effects
10.2 Longer-term experiences
10.3 Negative effects
10.4 Experiences following the ending of palfium treatment
10.5 Summary
11. Influence of palfium on the use of illegal drugs
11.1 General
11.2 Urine tests
11.3 Interviews
11.4 Interaction between cocaine and heroin use and the influence of palfium
11.5 Method of use
12. Commentary
Literature
Appendices: (for now not included in the Web version of 'Two mangoes')
I & II Medical check-up/MGO protocols
III Treatment contract/informed consent
IV Decision-making chart for the treatment of opiate-dependent prisoners (Ministry of Justice)

Two mangoes in 1979

George came from Surinam, from the countryside around Saramacca. A sculptor, a master in the art of living - and from the early 1970s an opium, and later heroin, addict. He was first encountered by the recently-formed Drugs Department of the Amsterdam Municipal Health Service in 1979, suffering from double pneumonia. Following mediation at the Binnengasthuis clinic, he was successfully treated. The next meeting was during the medical consultation hour at the Stadsdoelen centre, during an occupation of that building by a large group of Surinamese addicts. 'Herr Doktor,' he said, 'you've helped me a lot,' and with a flourish presented the doctor with two green mangoes - at that time, still an exotic, unknown delicacy in the Netherlands. Over the following decades, George was an occasional visitor to the Drugs Department, often coming to ask for help with an acute health problem. He knew exactly who he wanted to see: 'Herr Doktor' - who then received a full account of his ups and downs during the intervening period.

George very much wanted to take part in the palfium trial: life on the streets was becoming increasingly difficult for him at the age of 53. He was also one of those clients who clearly benefited from it, although it obviously did not prevent him from succumbing to lung cancer. He died of this in 1996.

George's life in Amsterdam, which he in part shared with the history of addiction treatment here, is a striking example of the condition of many of our clients: Amsterdammers with chronic health problems, which are a reaction to the characteristic lifestyle of opiate addicts.

We therefore dedicate this report to George R. (Saramacca 1941-Amsterdam 1996).

Giel van Brussel
Marcel Buster
Dirk van der Woude

1. Foreword

In early 1995, the Amsterdam alderman responsible for medical and health matters, Mrs. G. K. T. van der Giessen, asked the municipal health service, the GG&GD, to undertake a trial of the intoxicant opiate palfium, by prescribing it to a limited number of chronic heroin addicts in the city. These were to be addicts who in recent years had been unable to sufficiently regulate their lives to the minimum acceptable extent with the help of the non-intoxicant opiate substitute, methadone. In this context, the function of palfium can be explicitly compared with that of the intoxicant opiate heroin.

Under the influence of various social and sociomedical problems associated with opiate addiction, there has been much debate in recent years about the possible results of prescribing heroin on an individual basis. This discussion is not new, and is more or less cyclical in nature 1.

The background to this discussion is partly formed by an inadequate perception of the results of Dutch sociomedical drugs policy. One significant result of this is that several tens of thousands of addicts have survived this phase of their lives and no longer use opiates. Moreover, the number of new young addicts has dropped sharply, and in international terms the Netherlands has both a very low mortality rate from overdose and a high life expectancy for addicts. Unlike in other Western countries, the Dutch heroin epidemic has actually been declining for some years 2.

The current group of opiate addicts consists principally of a chronically dependent residual group, many of whom have been addicted for periods of longer than 15 or even 20 years and whose prognoses for permanent abstinence must be regarded as limited. Such a group of opiate addicts occurs much less frequently elsewhere, mainly as a result of their high mortality rates.

Sweden, for example, reports an annual mortality rate of almost 10 per cent, many times higher than in the Netherlands 3, 4, 5, 6, and in 1996 Germany recorded approximately 1800 overdose victims, more than six times the rate per capita 7, 8 in the Netherlands. Moreover, these countries have a much more explicit addiction treatment policy than some other European nations.

Analyzed from a policy perspective, it can be seen that there does in fact exist no directly curative approach for opiate addiction; rather, adequate treatment ('care') can result in a very high percentage of sufferers achieving the desired result: natural recovery.

This does not detract from the fact that the periodic revival of the debate about the individual supply of intoxicant opiates ('heroin on prescription') is rooted in a deeply-felt dissatisfaction with the current situation. Thanks to the extensive provision of differentiated health care, the sociomedical condition of most opiate addicts is good. However, there does exist one group which is visibly suffering 9. The possibility of courts imposing compulsory treatment has grown significantly in recent years. Public dissatisfaction is related to the recidivist character of criminality and drug use. However, this is a case of selective perception. In the media, for example, 'regulated' drug users such as the more than 1000 Amsterdam opiate addicts who receive their methadone from their own general practitioner, and the tens of thousands of former addicts, are 'invisible'. In addition, the so-called 'addiction problem' is to a certain extent an umbrella term under which all sorts of social problems are - sometimes unjustly - included 10, 11.

In this tense context, the heroin debate has been strongly revived in recent years. The city authorities have taken the position that individual medical treatment with heroin forms one possible method of positively contributing to the reversal of the vicious circle of social degeneration suffered by and around the group of chronic long-term addicts described above.

The possible effects of this, however, fall outside the scope of the palfium trial, and hence also outside that of this evaluation.

For legal reasons, doctors cannot use heroin itself in their regular medical practice, nor prescribe it as an individual medicine. For these reasons, alternative 'intoxicant opiates' have been sought in recent years. For intravenous drug users, morphine and methadone - which when injected does have an intoxicant effect - can be used in this respect, with a mainly palliative indication (the reduction of suffering). These substances have been reasonably effective for a considerable number of clients, particularly in terms of improving their treatment relationship and regulation status 12. However, it does appear that in the clients' experience the effects of these drugs differ considerably from the intoxicating 'high' they obtain from heroin. From the perspective of disease prevention, one problem with these opiates is that they are only suitable for intravenous use. In Amsterdam, this method of use has declined rapidly in recent years, so much so that only 40 per cent of the city's users now inject. For the remainder, the intoxicant opiate palfium - taken orally in pill form - is the first heroin substitute to have been introduced.

Palfium is an intoxicant opiate with a short effective period and strongly lipophile characteristics, which means that it rapidly penetrates (body) fat and therefore also the lipoid barrier which protects brain tissue. Following intake, the substance reaches the brain very rapidly and thus causes opiate intoxication. The pharmacological action of the substance is analogous to that of heroin: it is a strong, addictive painkiller. Because of its addictive properties, this substance - developed by Jansen in 1956 - is no longer used in ordinary medicine. Palfium is still sometimes used, though, as a palliative treatment for severe pain.

The palfium treatment for long-term heroin addicts began on 1 March, 1995. By 1 October, 1996, the observation date, a total of 53 clients had been prescribed palfium as an individual palliative; prescription included a treatment plan and informed consent. For two-thirds of the clients treated, the results were positive. For those clients whose treatment objectives were not achieved, the prescription of palfium could be ceased without problems, by agreement with the client. Palfium is no 'wonder drug', but for carefully-selected chronic heroin addicts it is a valuable tool in the struggle towards regulation. As such, the conclusions of the interim evaluation report of October 1995 still apply. Throughout the one-and-a-half year observation period, the treatment appears to have remained safe.

For this report, the condition of all the clients was discussed with them during the first week of October 1996, on the basis of an individual evaluation. The information reported comes from their patient files and urine tests, as well as from interviews with the individual clients. It should be noted that this evaluation does not constitute a scientific study with a control group, but is rather a systematic report of systematic actions with regard to such matters as:

  • the indication thesis;
  • the treatment plan;
  • monitoring, etc.

The report describes the experiences of the individuals treated in this way by the GG&GD. It successively considers the following points:

  • the objective of the project;
  • the nature of the target group reached, and the procedures followed with respect to selection, indication and positioning method;
  • the organization of the project;
  • those clients nominated for indication, and the progress of the treatment over time;
  • the use of illegal drugs;
  • morbidity and mortality within the group;
  • the clients' opinions about palfium:
  • * palfium or heroin treatment in the eyes of the clients;
  • * the effects of palfium as an intoxicant;
  • * social functioning.

2. Summary and conclusions

The palfium project described here began in March 1995. By the observation date, 1 October, 1996, palfium treatment had been begun for 53 clients; in the meantime, 23 clients had left the programme for one reason or another. Thirty clients were still receiving palfium, provided by either the GG&GD or their general practitioner. An impression of the progress of the palfium treatment was gained through desk research and interviews.

* treatment a succes with sixty percent of partcipants

The palfium treatment evokes, in terms of the predefined targets, a positive effects with sixty percent of the participants. This regards those persons that reach a rush from palfium that can be compared with that resulting from the use of heroin. Important is the level of social regulation.

* Duration of addiction and substances used

The clients who were considered for palfium treatment were chronic heroin addicts with an average age of 43, who had on average been addicts for 21 years. Of the clients, 81% have been known to the GG&GD for at least 10 years. The clients to whom palfium was given were overwhelmingly multiple drug users. At the start of the trial, 96% used heroin, 90% cocaine, 49% benzodiazepines and 17% excessive alcohol. Heroin was almost always used daily, and cocaine regularly.

* Satisfaction with the drug

The majority of the 45 clients interviewed for this and the interim report (69%) considered palfium to be satisfactory to good. The other 31%, however, were dissatisfied and considered the effects (or the absence of effects) of palfium to be negative. It is notable that of those subjects for whom the effects of palfium were negligible or negative, the majority (86%) stopped using it prematurely. Partly as a result of this '(self-) selection', 90% of those still taking palfium are satisfied with the drug.

* Mortality

It is known that one-quarter of the clients are HIV positive. Much of the morbidity within this group is also HIV related. By 1 October, 1996, only one person had died, caused by lung cancer. During the preparation of this report, however, two more clients have died, both from AIDS.

* Psychopathology, social functioning and imprisonment

One indication of the high level of psychopathology within this group is provided by the fact that one-quarter of the clients have at some time been patients in a psychiatric institution. Only 13 of the clients have their own home. Most, however, do have some kind of accommodation - in a hostel, with family or friends - and only one client was sleeping on the street. With only a few exceptions, virtually all the clients claim state benefits. For one-third of them, this income is managed by someone else. Half of the clients have a history of more than two years imprisonment, calculated cumulatively.

* Intoxication comparison

Compared with that of heroin, the general impression of the palfium 'high' is that it is less languorous, less intense and shorter lasting. Palfium is in general regarded as a heroin surrogate of lesser quality, with only one individual preferring it to heroin as a result of its stimulant effect. The difference in effect, the shorter 'half-life' and the method of ingestion - swallowing, rather than 'smoking the dragon' (smoking from tinfoil) mean that palfium can only fully replace heroin for a small number of clients.

* Reduced heroin use; stable cocaine use

Both the urine tests and the interviews showed that those clients who continued the palfium treatment reduced their heroin consumption. Only a small group, however, completely stopped using heroin. The majority only reduced their use of heroin. On the other hand, among the group which stopped the palfium treatment, heroin use remained unchanged. The palfium treatment did not lead to a clearly demonstrable reduction in cocaine use. However, this data shows that the fear that reduced heroin use would be compensated for by increased cocaine use was unfounded. What can be seen is that reduced heroin use is accompanied by mostly unchanged, and sometimes reduced, cocaine use.

For the group as a whole, the urine tests and interviews show that heroin use declined, whilst there was no significant increase or decline in the use of cocaine and benzodiazepines. For the vast majority, cocaine was used in 'crack' form, which is also regarded by the clients as potentially strongly intoxicating.

* Return to methadone not problematic

Stopping palfium does not in general lead to major problems: an increase in the dosage of methadone is sufficient to prevent withdrawal symptoms. However, stopping palfium without methadone compensation during a period of imprisonment does give rise to problems. Confidence in the methadone treatment is high, including amongst the group which stopped taking palfium. No serious incidents or deaths occurred as a result of using palfium. Five clients stopped taking palfium and transferred to methadone treatment as a result of negative symptoms which they ascribed to palfium. One of these lost consciousness as a result of combining palfium with excessive alcohol, one became confused after several weeks and suffered fits of weeping, two others became restless because of the short effective period of palfium, and a fifth noted that he was 'getting used' to palfium and so decided to stop taking it.

* Benzodiazepine use contra-indicative

The use of benzodiazepines leads to a reduction of the intoxicating effect, with the result that there is a greater chance that the palfium treatment will fail. Ethnically Dutch clients, in particular, use benzodiazepines daily. As a result, the palfium treatment was primarily successful among the ethnically Surinamese/Dutch Antillean clients, who use fewer benzodiazepines. The chance that the palfium treatment will be ended is greater amongst clients who use benzodiazepines: they have less control over their emotional lives. Additional psychopathological problems could be the underlying cause of this.

* Social base and lifestyle require attention

Amongst those clients without a firm social base (in the form of housing, a partner and/or family contacts), palfium treatment is not sufficient to improve this base. For this group, especially, achieving a satisfactory lifestyle remains a major problem. Amongst those clients who do have a firm social base, palfium treatment does assist in consolidating or strengthening this base.

* Applicability of palfium in relation to heroin medication

Palfium acts less intensively than heroin, but offers the user more freedom than would be the case with a strictly controlled heroin treatment. Palfium is as attractive as heroin only for a very few people. In the longer term, therefore, palfium treatment is not an effective alternative to a possible heroin treatment. It is, however, a viable option for those clients who would find the obligation to undergo heroin treatment 21 times per week in a controlled location (and the consequent hospitalization) unacceptable.

3. Objective

The objective of the project is to investigate the possibilities and limitations of palfium treatment for chronic heroin dependents with serious social and/or medical problems.

The first question regarding the use of palfium as a substitute for heroin is whether palfium is attractive to the clients as an intoxicant opiate in the form provided. In other words, does palfium give a 'high' which is comparable to the heroin 'high'? After all, if this is not the case then no improvement can be expected by comparison with the standard methadone treatment.

For each individual client, the objective was to reduce heroin use. In addition, objectives were set based upon individual personal problems, such as:

  • ceasing intravenous drug use;
  • improvement of social functioning, including arranging health insurance, housing and/or daily expenditure;
  • seeking medical treatment for specific health problems;
  • restoration of family relationships;
  • etc.

4. Target group/Admittance criteria and admittance thesis

The target group for the palfium treatment consists of chronically heroin-dependent Amsterdam drug users, who have made use of the assistance facilities - in particular the GG&GD's low-threshold methadone treatment - over a long period, without having succeeded in achieving an adequate level of functioning through them. The basis of the admittance thesis is the assumption - based upon the length of their addiction and their documented prior history - that the need for heroin amongst the individual patients is irreversible, or at least cannot be influenced through pressure or coercion. In addition to this chronic need for heroin, there should also exist serious suffering as a result of inadequate self-care or neglect.

In summary, the criteria for admittance to the palfium trial are:

  • legal residence in the Netherlands;
  • poor psychological, social and/or physical condition;
  • long-term and documented opiate addiction;
  • long-term treatment with significant dosages of methadone by the GG&GD;
  • continuous usage of heroin during the previous year indicated by urine tests, despite the methadone treatment;
  • no attempt to end opiate usage during the previous year;
  • voluntary desire to undertake palfium treatment.

Every three months, the Drugs Department of the GG&GD carries out an extensive periodic health and social check on each client, to investigate their functioning with respect to such aspects as addiction, psychiatric and somatic co-morbidity and social integration (see Appendix I for an overview of the specific criteria). Opiate addicts are aware of information from the mass media and frequently ask about the possibility of participating in both heroin and palfium treatments. Both this palfium trial and the earlier trial with heroin treatment were much discussed within the drugs scene. This fact can partly be interpreted as indicating the great desire amongst many opiate addicts to escape the the apparently hopeless heroin 'trap'.

If a client asks to take part in the palfium treatment, an individual sociomedical assessment of the request takes place. If the client fulfils all the criteria for the target group and the inclusion criteria for the palfium treatment, then a treatment plan is drawn up in consultation with him or her. This encompasses the actual content of the treatment, namely: the daily receipt of a possibly sufficient dosage of a substitute intoxicant opiate, on the condition that the general functioning of the subject clearly improves.

One element of the treatment is the consideration, together with the client, of the objectives which he or she should achieve within the context of the project, and what additional policy is required to do so.

The recommendation is assessed by the medical management of the Drugs Department, and forwarded to the medical director. If the recommendation is approved, then an individual treatment agreement (see Appendix II) is then drawn up, to be signed by the client and by the treatment worker concerned. This treatment agreement also acts as a statement of 'informed consent'.

5. The treatment

Palfium is provided in 5mg marked tablets, with dosages ranging from 15 to 50mg. The average dosage is 30mg. Three quarters of the clients receive 25 or 30mg per day. The palfium is provided in combination with methadone; the average methadone dosage is 75mg, and the range 10 to 170mg. Most of the clients (60%) received between 60 and 120mg of methadone. The palfium is provided daily and, with a few exceptions, taken throughout the day. The progress of the treatment is checked through urine tests, with not only the palfium marker but also the whole spectrum of psychotropic substances being analysed.

The Drugs Department follows the client throughout the treatment and systematically motivates him or her with regard to the specific care objectives outlined in the treatment agreement. These vary from the cessation or reduction of heroin use to medical objectives such as obtaining effective treatment for AIDS, carcinoma and/or dental problems, and social objectives such as the restoration of family relationships, management of benefit payments, arranging housing and/or finding a useful way of spending time, etc.

Medication level

During the course of the treatment, the optimum level of medication is sought. This involves finding a dosage high enough that the 'high' desired by the client is achieved, but low enough that he or she avoids being upset by excessive fluctuations between intoxication and normality. Problems can particularly arise during the weekend, if the medication is used up by Sunday as a result of overconsumption on Friday and Saturday.

6. Data-collection method and project organization

6.1 Introduction

The palfium treatment is implemented by and integrated into the work of the Drugs Department, which is already very busy with the regular methadone treatment of problematic drug users. At the same time, the method of working forms part of the normal primary care process.

In the first instance, the emphasis was upon the medically-sound selection and guidance of clients who could benefit from palfium treatment. In addition, a computerized registration system had to be developed specifically for this project. However, during this phase it was primarily guidance under medical supervision which was emphasized.

During the first six months, Mr. Minjon of the Jellinek Foundation (for addiction research and counselling) offered his help with handling the contracts; the support of Mrs. Weijers of the Jellinek Laboratory was, and remains, excellent. At the start of the project, it was possible to take six clients from the Jellinek's CODA 13 for diagnosis and observation during the introduction of palfium. This procedure was accompanied by an intensive study of blood samples by the Coronel Laboratory of the AMC hospital, and of the changing level of the craving for heroin over time. At the same time, fractioned 24-hour urine was collected for palfium measurement.

6.2 Data-collection method

Of the 53 clients who started the palfium treatment, 39 were personally interviewed by the two first-named authors of this report following the observation date (1 October, 1996). During this interview (Appendix III), the subjects covered during the quarterly health check were discussed and expanded upon. For a number of topics, particularly the subjective assessment by the users of palfium in comparison with heroin, use was made of the information gathered during the survey undertaken for the interim report on the first six months of the palfium treatment (October 1995). This related to seven additional clients who could not be interviewed for the definitive evaluation report. One person had already died, from a carcinoma of the lung, whilst the state of health of five clients was too poor for an in-depth personal discussion. The data collected orally was supplemented with information from the files and from treatment workers, and with the results of urine tests.

Of the 27 clients being treated with palfium by the GG&GD on 1 October, 1996, interviews could be held with 24. Because of their illness, interviews were not held with three clients suffering from AIDS; instead, information from their patient files was used.

Of the three clients being treated with palfium by their own general practitioner, one was approached for an interview whilst the two with a primary palfium addiction were not. However, for the description of the background characteristics of those involved information from their files was used.

For the eight clients who were no longer being treated with methadone by the GG&GD on 1 October, information from their patient files was also used. Of the 15 clients still being treated by the GG&GD with methadone, although no longer with palfium, 14 were interviewed. For the fifteenth, evaluation was undertaken using desk research.

Table 1: Status of clients as of 1/10/96



Number of clients
 
interview
 

palfium provided by GG&GD*

27
51%
24
62%

palfium provided by GP

3
6%
1
3%

some methadone provided by GG&GD

15
28%
14
36%

some methadone provided by GP

1
2%
-
 

in custody

2
4%
-
 

hospital

2
4%
-
 

died

1
2%
-
 

unknown

2
4%
-
 

total

53
100%
39
100%

* Of whom one person recieving palfium from the GG&GD whilst in hospital.

Amongst this group, confidence with regard to the methadone and/or palfium therapy was high. On 1 October, 1996, 46 clients (83%) of those who had begun the palfium treatment were still being treated by their GP or the GG&GD with at least methadone. The whereabouts of only two of the remaining clients was unknown. Of the other five clients, two were in prison, two had been admitted to hospital and one had died, of lung cancer.

6.3 Urine tests

Weekly urine tests were carried out during the palfium treatment. This was done to check that the palfium tablets were actually being used, and was made possible by the addition of a marking substance to the tablets. A qualitative overview of overall drug use was also obtained in this way. As stated earlier, in a technical sense the test is dichotomous: positive is positive, but it is not possible to evaluate any reduction in use through testing. Clients who receive methadone but not palfium also undergo broad-spectrum urine tests as part of their regular health check, so as to monitor additional drug use.

In this analysis, the urine is checked for heroin, cocaine and benzodiazepines.

For this report, the data from urine tests since 1989 has been studied. For each patient, all urine test results from the period prior to the start of the palfium treatment, and from the subsequent period, have been examined, whether or not their palfium treatment has been ended. For 51 clients whose urine test results were available from both the years before and following the start of the palfium treatment, the variations between these two periods were studied. In doing so, the average percentage of positive urine tests and the percentage of clients whose last urine test was positive were examined. On average, the clients had taken 24 urine tests prior to the palfium treatment (since 1989) and 22 since it began.

6.4 Regular medical checks

Every client of the Drugs Department undergoes an extensive medical check-up (PGO) once every quarter, the data from which is added to their file. The PGO encompasses the following subjects:

  • current addiction status, including method(s) of use;
  • HIV/AIDS status, including counselling;
  • social status, including housing, income, health insurance, daily routine;
  • physical status, based upon a physical examination;
  • psychiatric status, based upon a psychiatric examination;
  • broad-spectrum urine analysis.

7. Treatment progress

7.1 The client group

Between March 1995 and 1 October, 1996, a total of 53 clients were treated with palfium. The average age of the group - which on the observation date was 43 years, with a range of 28 to 66 years - differed from that of all the clients who made use of the GG&GD's methadone treatment programme in 1995, which was 37 years. Palfium was provided to eight women (15% of the group). The average age of these women was 38 years, and the average age of the men was 44 years. Their backgrounds reflected the ratios within the total client group of the Drugs Department. Of the clients, 28 (52%) are of Dutch origin, 20 (38%) originally came from Surinam and three (6%) from the Dutch Antilles. In addition, two clients originally came from Germany and France respectively, both having already resided legally in the Netherlands for a long period.

Their periods of addiction were long, ranging from 14 to 30 years, with an average of 21 years. They became addicts at an average age of 22 years, which in an international perspective is relatively late. At the time of indication, the majority (64% of the clients) were taking drugs orally ('smoking the dragon'). The remainder of the clients were taking them intravenously. The clients had mostly been known to the GG&GD methadone treatment programme for a very long time (on average 12 years). Half (51%) of them registered for methadone treatment during or before 1982; 81% per cent of them were registered in 1986. Two male clients with an addiction to palfium were only referred to the GG&GD treatment programme in 1995 and 1996, respectively. One of these, aged 65 on the observation date, had already become primarily addicted to palfium in 1977. The other, aged 44 on the observation date, began his opiate addiction with heroin. For the past seven years, he had 'exchanged' this substance for palfium.

Table 2: Origins of the clients, subdivided by sex and method of use:


Origin

total

female

intra-venous use

Dutch

28

7 (25%)

15 (54%)

Surinamese

20

-

2 (10%)

Antillean

3

-

1 (33%)

Other

2

1 (50%)

1 (50%)


53

8 (15%)

19 (36%)

Table 3: Substances used on intake:

Substance
Number of users
heroin
53* (100%)
cocaine
46 (90%)
benzodiaze-pines
26 (49%)
excessive alcohol
11 (21%)

* Two clients had not been using heroin for some time, but rather illegal palfium. Both have subsequently been treated with palfium by their GPs.

7.2 Client intake during the trial

At the start of the palfium project, two clients had already been treated with palfium since 1993, to ease chronic pain (from AIDS). Following the start of the trial, another 33 clients began palfium treatment during 1995, and a further 18 during 1996.

On the observation date, 1 October, 1996, 23 clients had stopped using palfium. The duration of their treatment varied from two weeks to 11 months, with an average of 4.6 months. Of the 30 clients still receiving prescription palfium, the average duration of the treatment since March 1995 was 12 months, with a range of one-and-a-half months to one-and-a-half years.

Table 4: Cumulative overview of start and end of palfium treatment during the trial



Start of treatment

End of treatment

Being treated at end of trial

before March 1995

2

0

2

March 1995 to Aug. 1995

19

2

19

Sept. 1995 to March 1996

24

9

33

April 1996 to Sept. 1996

9

12

30

total

53

23

7.3 Reasons for ending the palfium treatment

When asked, the clients gave a wide variety of reasons for stopping taking palfium. The predominant reason was too limited a perception of an effect: "I don't get much from it." Five clients experienced negative effects, which in two cases were expressed as increasing restlessness, resulting in upset and decline. This upset was however transient, with recovery following the ending of the palfium treatment. It is notable that all those who stopped the treatment were able to do so without major problems. The withdrawal symptoms resulting from ending palfium use could be easily overcome through a relatively limited increase in the daily methadone dosage (see also section 10.3: negative effects).

Table 5: Reasons for ending the palfium treatment


reason

total

no effect / continued use of large quantities of other drugs

10 43%

negative effect

5 22%

suspected sale

3 13%

death

1 4%

anxiety following ending of benzodiazepine use

1 4%

imprisonment

1 4%

non-cooperation with treatment

1 4%

blackmail by other users

1 4%

totaal

23 100%

8. Morbidity/mortality

A high rate of serious morbidity (illness) arises amongst those clients who were considered for palfium treatment. So, for example, one client whose recommendation for palfium treatment had been approved died of heart failure before the palfium treatment had actually begun. This example illustrates that treatment with this substitute intoxicant opiate also primarily has a palliative function: easing the suffering of seriously-ill clients. One other palfium client died during the trial period, of a bronchial carcinoma.

Causes of death and illness which occur more frequently amongst chronic opiate addicts compared with the total population - such as fatal overdoses, suicide, accidents and the like - did not occur within the study group during this period.

* HIV/AIDS

It is known that 14 of the clients (26%) are infected with HIV. Of these, eight subsequently developed full-blown AIDS and one died - as previously mentioned, not as a result of AIDS but from a metastatic lung carcinoma. Between the observation date, 1 October, 1996, and 31 December, 1996, two more clients from this group died of AIDS.

* Hospital admissions

Seven of the eight clients with AIDS were admitted to hospital, where in addition to their AIDS-related diseases (three with pneumonia, one with candida oesophagitis, and tuberculosis and AIDS-related dementia) one testicular carcinoma and one lung carcinoma were detected. In one case, the admission was related to bronchial asthma. In addition to the seven clients with AIDS, five others have been admitted to hospital during the past year: three following accidents or violence, one for an eye operation and one with pneumonia.

* Recurrent chronic illness or past illness

In addition to these clients, some others were not admitted to hospital during the period of palfium treatment but were still recovering from or under observation in connection with earlier chronic infections or diseases: a colonic carcinoma, a serious hip inflammation caused by an abcess, an endocarditis and a meningitis, tuberculosis and two clients with asthma.

* Injection-related infections

Three clients were put on palfium as a consequence of the appearance of very serious and recurrent general infections resulting from injecting.

In one client, this led to an endocarditis, and in another to the amputation of an arm. The objective with these patients (achieved by two of the three) was to stop them injecting.

* Psychiatry

Thirteen of the clients had at some time been in psychiatric care, and in four cases the psychiatric admittance (which was abroad or, in one case, 20 years ago in the Netherlands) was intended to end their addiction. One client had once had TBR (judicial controlled mandatory treatment in a psychiatric facility after a criminal offence).

9. Social circumstances

9.1 Incomes

None of the clients was in paid employment on the observation date, 1 October, 1996. In this respect, the group differs from the overall population of opiate addicts in the Netherlands, at least 20 per cent of whom are in paid employment according to a recent IVV (Organization for Information Systems on Addiction Care and Treatment) report. Virtually all those in the trial group (50 clients) were receiving state benefits, with only three clients not. These clients also did not therefore have any health-care insurance. One of them, despite repeated requests from the treatment workers, refused to do anything to rectify this situation, which under the terms of the treatment contract led to the palfium treatment being ended.

Table 6: Income situation


Type of benefit

Total

Disability (AAW, WAO)

16

Widows'/unemployment (AWW, RWW)

15

Basic welfare (ABW)

8

Partners'/Family benefit

3

Old-age pension (AOW)

2

Unspecified benefit

8

No benefit

1

Of the 50 clients receiving state benefits, those of 18 were managed by third parties - in 12 cases by bodies established for this purpose, such as the Stichting Inkomens Beheer (Income Management Foundation) and the Stichting Uitkerings Beheer (Benefits Management Foundation). For three of the clients, the management was undertaken by their hostel and for three others by their parents or (non-drug using) partner. At least 11 clients had large financial debts, ranging from NLG 2000 to NLG 100,000.

9.2 Housing

The housing situation of all the clients surveyed is known. Two-thirds of them (34) had their own home, either with or without a partner. Seven clients were living in hostels: two in hostels run by voluntary organisations and five in commercial hostels. Three clients were living with one or both parents, one was staying temporarily with friends, one temporarily with a brother and one was living on the streets. Four clients were staying in hospital (of whom one has died) and two were in prison. Of these, only one had no permanent home or place to stay, but during 'clean' periods was able to stay with a friend.

Despite the extent of the housing problems amongst this group, all but one had a roof over their head. Voluntary and commercial hostels, as well as family and friends, do take in homeless drug users home. One person had been sleeping on the street for a short period after a short-term sublet ended. This situation did not result from a lack of places in hostels for the homeless, but was because he objected to the method of working of the various organisations, such as the Salvation Army - "You can only stay there for three days" - the HVO (Help for the Homeless) - "I'm sick of the gowns you have to wear there" - and the 'Chairs' project - "I can't see myself sitting there, either."

The housing situation of the palfium clients hardly seems to have improved. Those clients who did not have their own home before the palfium treatment still do not have one. But palfium treatment can have a function in clients keeping their own home. This result can be illustrated using examples such as that of one client who, following a period of homelessness, found a home through a 'managed living' scheme. His chances of losing his home again are now much smaller, as the palfium treatment has minimized his drug use.

Another client tells the following story: "The housing association tried to get me out. That was because, before I had palfium, I got heroin from users who I let live with me in return for it. There was a whole load of them. When I got palfium, I was able to get them out. I'm not so dependent on them any more."

Moreover, when the palfium treatment fails, this sort of problem - drugs being exchanged for accommodation, resulting in problems of order - continues. One client, whose palfium treatment was stopped because he was selling the drug, says: "I rent a flat, but it's a bit of a mess. I've got three more Yugoslavian users visiting. They stay with me, and in return they make sure that there's something to take."

9.3 Lifestyle

How to spend their time remains a major problem for the group of palfium clients. For most, their activities are limited to household chores, walking around and watching TV. Many also complain of boredom, whilst some also say that their illness (HIV, hepatitis) makes them too listless to do anything.

In general, clients without their own homes have the most difficulty with their lifestyle: "I walk around a bit, wander through the streets, play a game of pool or watch TV; I'm tired of the same routine all the time." Clients with their own home have household activities to do, and can devote time to looking after their home and caring for a pet.

A satisfactory lifestyle is strongly related to social contacts outside the drug scene, and if these contacts improve some clients are given odd jobs. Contacts with family - "I often look after my sister's children, and I pick them up from school; she can still count on me" - with a partner - "My boyfriend has a company where I help out: I clean and answer the telephone" - or with friends outside the drug scene - "I play in a band with friends who aren't users; during the week I practice and at the weekend I perform".

In this respect, there is a clear analogy with the importance of the social network noted in regular psychiatric care and help for the homeless.

When looking for a job, this group - the majority of whom have a criminal record - are haunted by their past: "With my record, I find it difficult to get a job, so during the day I look for old metal and retrieve copper wire from old buildings. I see this more as occupational therapy."

9.4 Relationships and social contacts

Twenty of the 53 clients have a regular partner. One-quarter (13 of the 45 male clients) of the men and seven of the eight women have a partner; only two of these partners are themselves drug users. It appears to be easier for the women in this group to find a regular partner and to maintain the relationship (Fisher's exact test, p<0.05). Stable relationships are also associated with adequate housing (chi sq.: 3.9, df=1, p<0.05). Of the men without a permanent home, none has a regular relationship. For at least two of the men, the breakdown of a relationship several years ago also marked the beginning of a period of homelessness. This causality is also observed amongst many non-addicted homeless men.

As regards family ties, there exist wide extremes. Three clients live with their mother or both parents and several others have contact daily or several times per week with their mother. On the other hand, there are also clients who no longer know whether they have family or who believe that contact with them has irretrievably broken down. One client, however, has renewed contact with his father after meeting him at the funeral of his sister, who had committed suicide.

Several of the clients studied have children, and four of them are grandparents. For them, the palfium treatment sometimes led to a moving social recovery. One HIV-positive clients says of her renewed family contact: "I'm in contact again with my brother and I have found my son. My son was also an addict, but fortunately not HIV positive. In the meantime, I had become a grandmother."

9.5 Imprisonment

Information was received from 46 clients about their history of imprisonment. Of this group, 85 per cent have been in prison. Their cumulative period of imprisonment range from a few weeks - for unpaid fines, for example - to 12 years for armed robberies. On the other hand, seven clients (15%) have never been in prison, whilst for many clients (37%) their cumulative period of imprisonment was less than two years. In those cases, this usually comprised several short periods of detention.

Table 7: Imprisonment


cumulative imprisonment period

total

never

7 15%

less than 2 years

17 37%

2 - 5 years

10 22%

5 - 10 years

9 20%

longer than 10 years

3 7%

total

46 100%*

* sufficient information was available about 46 clients

Many clients, for example, repeatedly disappear behind bars for short periods as result of not paying fines for such offences as fare-dodging: "I've regularly been sent to prison for fines, often for just a few days or a week. You get the choice of paying or going to jail; I can't pay so I go to jail." Actually paying fines is the exception rather than the rule: "Although it's against my principles, I actually paid a fine recently." One 65-year old man says: "I'm much too old for it; they're all young guys in there - I'm really ashamed of being in there among them." Better co-operation between the social services, benefits management agencies and the police and courts could avoid such custody in the future.

9.6 The social situation of palfium clients: a subjective impression

One striking thing shown by the interviews is that there are clients within this group with a average of 21 years of addiction who have not entirely lost all the social basis provided by a family, partner and housing. Some have even built these up during their addiction.

For this group in particular, palfium appears to be a suitable aid in consolidating of broadening their social basis. Reducing or ending illegal drug use gives them peace of mind. Moreover, this group is rewarded socially through improved contacts with their partner, family, friends or neighbours. These improved contacts sometimes lead to a useful allocation of their time.

There are wide variations in social circumstances within the group of (former) palfium clients. Members of the worst-off group have no home, wander through the city all day, and have no partner and no social contacts outside the drug scene. Even with palfium, this group without exception still uses a lot of other drugs. Their social circumstances, in which their trusted drug scene forms the only support, keeps drug use at the centre of their lives.

It is exactly this group, moreover, which overwhelming creates the public impression - which at best can be called incomplete - of drug addiction: the socially-degenerate street 'junkie'.

The relatively best-off group live in circumstances in which there still exists a social basis, consisting of their own home, a partner and/or family contacts. This existing balance is however vulnerable, with a real risk that the basis will be lost through drug use, resulting in further inevitable losses. For these clients, palfium treatment can provide a helping hand. Such matters as housing and the relationship with the partner or family can be maintained or improved. Although additional drug use does still occur, the use of heroin and cocaine is less compulsive and less of a "conditio sine qua non".

Both groups include clients with psychiatric conditions which have a strongly destabilizing effect. Amongst those clients without a social basis, the existence of psychopathology in combination with opiate addiction forms an additional obstacle to building up a basis, whilst for those with precarious stability it contributes to the risk of losing this.

10. The individual subjective effect of palfium

For the individual evaluation of the palfium treatment on the 46 clients with whom the researchers spoke personally, a great deal of emphasis was placed upon their subjective appraisal of the effects of palfium. Using a semi-structured interview, such subjects as the following were discussed:

  • the perception of the intoxicating effect of palfium, compared with that of heroin;
  • the time of day when the palfium tablets supplied were consumed;
  • possible negative effects, either physical, psychological or social;
  • the impact of the palfium treatment on individual spending behaviour with respect to the purchase and use of heroin and cocaine.

The majority of the 46 clients (69%) considered palfium to be satisfactory to good; 31%, however, were dissatisfied and considered the effects (or the absence of effects) of palfium to be negative. It is notable that of those people on whom palfium had no, or a negative, effect, the majority (86%) had already stopped using it. Partly as a result of this (self) selection, 90% of those still receiving palfium are satisfied with the substance.

10.1 Intoxicating effects

The palfium 'high' is not experienced by everybody, particularly during the first weeks of use. If an intoxicating effect does occur, this is described as a warm, comfortable feeling, which is less intense than a heroin 'high'. The so-called 'rush' which takes place during the intravenous use of heroin does not happen. With a few exceptions, those who smoke heroin also say they experience a lesser effect from palfium.

The intoxication differs from a heroin 'high' in that palfium contains a stimulant. In particular, the narcotic, dazing effect of heroin is lesser with palfium: "With palfium you don't get stoned, you talk more more and you can do things." The stronger painkilling effect of palfium is also cited as a difference. Two clients with back problems and one person with AIDS and unexplained pain saw this difference as a positive aspect of palfium. Most clients, however, prefer heroin to palfium: "Nothing is like heroin, nothing." Only one person said they preferred palfium, the reason being its stimulating effect: "I find it better than heroin because you don't get completely stoned, and I'm too proud for that."

By comparison with those of heroin, the duration of the effects produced by palfium are shorter to much shorter. It acts rapidly following oral intake, with a light, warm 'glow' throughout the body. The treatment did not succeed with those clients for whom this effect was only very short-lasting. For most of the clients, however, the effects of palfium lasted one-and-a-half to two hours. During the treatment programme, palfium for the weekend was also distributed on Friday, which caused half the clients to have problems on Sundays due to overconsumption of the palfium on the previous Friday and Saturday. Some clients protected themselves against this risk by allowing (non-drug using) third parties (their partner or parents) to look after their palfium.

10.2 Longer-term experiences

As with the experiences of its intoxicating effects, wide individual variations were found with respect to experiences of longer-term effects of palfium.

The general picture was that only after an initial phase of several days to several weeks with no or relatively little effect being felt was the specific palfium 'high' recognized. This does not mean that there were not clients who immediately felt the strongest effect during that first phase: "The first weeks were the honeymoon weeks." Over the longer term, palfium retains its effectiveness, although the feeling of intoxication declines somewhat. Moreover, the duration of the effect shortened for some clients.

10.3 Negative effects

During the evaluation, detailed questions were asked about the negative effects attributed to palfium. In this respect, it is important to bear in mind that the substance was distributed to a group of (multiple) drug users with a high morbidity rate. This hinders the identification of any side-effects of palfium. After all, it is often not clear whether it is the palfium use itself which causes physical or mental complaints, or whether these result from stopping the use of other substances or from the continuing progress of other illnesses.

The Farmacotherapeutisch Kompas 1996 (the Dutch pharmacopoeia) states that the most important risk in clients not addicted to opiates is the risk of the breathing stopping. This publication also notes the addictiveness of palfium when administered to non-addicts as a painkiller.

Within the palfium trial, the drug was prescribed to patients who had already been addicted to opiates for many years, and who had therefore built up a high tolerance for these substances. Fatal overdoses did not occur among the palfium clients.

Possible negative aspects of the palfium treatment can be categorized as follows:

  • the absence of a positive intoxicating effect;
  • effects associated with the addictive nature of the drug;
  • effects (possibly) associated with the stoppage of other medication or drugs;
  • negative physical or mental effects linked with palfium (given the already existing opiate dependency);
  • negative effects on ending the palfium treatment.

* The absence of a positive (intoxicating) effect

The palfium 'high' was not immediately experienced by a large proportion of the clients, and for a smaller group it remained absent even after a longer period. The absence of an (intoxicating) effect was experienced as negative by seven clients. Five of these stopped taking palfium during the trial, and one other stated during the interview that he was considering stopping. It is notable that of all those clients who did stop, only one did so involuntarily. The background to this was the continuing additional use of heroin, cocaine and in particular alcohol. One client who has persevered until now, despite the absence of a real palfium 'high', has succeeded in virtually stopping use of other drugs: "To be honest, it doesn't do much for me. At the start I didn't feel anything at all, but now I notice something comparable with smoking a joint - it kills the appetite. But I really wanted to stop with heroin: I only weighed 55kg and I looked like the type of junkie I had always detested."

* Dependency

Palfium is an opiate, and therefore an addictive substance which produces withdrawal effects on abstinence. The clients to whom palfium was provided have already been using other opiates such as heroin and methadone for many years. Because of the differences between the effects, method of use and possibly also the withdrawal effects of heroin, methadone and palfium, many clients see the three opiates - although wrongly - as substances with a different addictive action.

Two clients for whom palfium did not bring about a reduction in the consumption of other drugs considered palfium to be a pointless extra addiction. Both stopped using it after a number of months. One said, "When I received palfium, I was using Prozac, Valium, heroin, cocaine and alcohol. Palfium was added to them. It did make me quieter, but I continued to use a lot of other drugs. I thought that that couldn't really be the intention of the palfium treatment, and I didn't want to make a fool of myself or of you, so I stopped taking the palfium."

The method of taking palfium - swallowing tablets - differs from those of heroin: 'smoking the dragon' (smoking from tinfoil) and/or injecting. The use ritual is often missed. The palfium treatment of one person failed because their 'addiction to the needle' was too great and palfium did not bring about any reduction in heroin use. Clients who smoke heroin make similar remarks: "With palfium, you miss the ritual with with foil."

The relatively short effective period of palfium (one-and-a-half hours, as against about four hours for heroin) has various disadvantages. Firstly, this makes the use of palfium more difficult to manage than that of heroin, although it is more easy than that of cocaine - in particular processed cocaine ('crack') - which has an even shorter effective period. In order to prevent the palfium habit taking on extreme forms due to rapidly accumulating use, the GG&GD sets palfium dosages rather low.

Its rapidly cumulative, upsetting effect is the reason why palfium cannot simply be provided to the vast majority of the clients through their regular general practice. This forms an essential difference from the treatment with long-acting, regulating and non-intoxicating methadone. This treatment is currently available through 75 per cent of all general practices in Amsterdam, which provide it in an admirable way to about 25 per cent of all the opiate addicts entitled to treatment in the city.

Although virtually everyone mentioned its shorter effective period, only one person stated that palfium made him ill at ease. He explained that the effect of the palfium was already declining after half an hour, so that he took the next tablet then. As a result, he had already finished all his palfium by the end of the afternoon, after which he was left with a feeling of unease and a craving for more.

Six clients spoke about feeling sick and experiencing withdrawal symptoms in the morning. This probably refers to refers to initial withdrawal symptoms. It is possible that palfium leads to earlier withdrawal symptoms in the mornings, certainly with a relatively low co-dosage of methadone. After adjustment of the methadone dosage, these symptoms should disappear.

Two clients experienced the addictiveness of palfium as negative. For them, palfium did have a positive (intoxicant) effect resulting in a considerable reduction in heroin use. One of them, having first completely stopped taking heroin intravenously, subsequently stopped using palfium.

* Problems possibly related to the stoppage of other medication or drugs

For one client, who in addition to using heroin and cocaine was also taking a variety of other psychopharmaceuticals (Phenergan, Rohypnol and Valium), palfium was offered offered on the condition that he stop using pills. However, this made the subject anxious and aggressive, after which he stopped taking palfium. One client spoke of nightmares and pruritis, which are known side-effects of morphine but not of palfium; stopping taking tolvon could also be another cause of these symptoms. For this person, the symptoms cited did not constitute a reason to stop taking palfium. Another client explained that palfium had the desired effect for several weeks; she cheered up and was able to stop taking heroin. Then, however, for no apparent reason she started to feel confused, heard voices and suffered long fits of weeping. Although the palfium was continued for another week and the symptoms disappeared, she stopped taking palfium. She explained that she had experienced this once before after she stopped using heroin.

* Combination with alcohol

One person reported having fallen unconscious after taking palfium. He spoke of sleepiness, dizziness and impaired motor function. This client combined the palfium with (a lot of alcohol) and amphetamines. After having twice experienced the symptoms cited, he stopped taking palfium. One client with AIDS who was treated by his general practitioner with a weekly palfium prescription originally took more palfium during the first days in combination with a large amount of alcohol. This resulted in a drunken state during which he talked a lot and quickly became aggressive.

* Other symptoms possibly caused by palfium

One person spoke of being much troubled by palpitations, particularly during the first phase of use. Another complained of 'heaviness' in the head. One person believed that he had headaches more often because of the palfium, but that these disappeared by taking more palfium. Two clients suffered from forgetfulness, the possible cause of which in one case may have been meningitis in the past. Two clients complained of sweating, and two of acid indigestion. Another reported: "I've had a bit of cramp in my knee in the past few days - maybe that's caused by the palfium."

* Negative social effects and problems caused by palfium

Negative social effects include threats and harassment by other users and by dealers. Those clients of whom it was known by other users that they were receiving palfium were thus sometimes pressured to hand over or sell their palfium. Another client distanced himself further from his contacts in the drug scene, partly because of the tensions with other users; he now no longer uses any illegal drugs.

A second socially negative aspect of the palfium treatment is the possible sale of the tablets received to other users or to dealers. The urine samples were therefore used to check that the palfium was actually being taken. Up to now, the palfium treatment of three clients has been ended for this reason.

10.4 Experiences following the ending of palfium treatment

Particularly among ethnically Dutch users, palfium has a bad name because of withdrawal symptoms. An historical explanation for this can be found in the nature of the more general past use of the substance in medical practice, and in the associated supplies in pharmacies. Very long-term addicts may have experienced the temporary wide availability of palfium in the drug scene following a large-scale theft from a pharmacy. During such a period, their daily dose of opiates would rise sharply due to the short effective period and the availability of quantities of palfium tablets. Once the temporary supply had been consumed, the period of intoxication would be followed by severe withdrawal symptoms.

Of the 23 clients who no longer receive palfium, 14 provided information about their experiences in stopping using it. The majority - nine clients - appeared to have suffered no withdrawal symptoms, although four of these had also not experienced a 'high' from palfium.

Of the five clients who did perceive withdrawal symptoms after stopping the use of palfium, two found the experience much better than they had expected: "I was clammy and sweaty for a while, but it wasn't as bad as people had warned me it would be." Three clients did have problems coming off palfium, though: "I still felt unstable for ages." And: "Fairly bad withdrawal symptoms which lasted at least a month; I'd also used a lot of brown [heroin] beforehand."

By far the most serious withdrawal symptoms appear during a period of imprisonment. Although the medication could in some cases be continued during a period of detention, this was not usually the case. As well as ending the palfium treatment, current practice in most detention centres and prisons is - incidentally, contrary to departmental guidelines from 1986 and 1996 respectively (Appendix IV) - to reduce methadone treatment drastically and end it rapidly. For one client, the enforced withdrawal from methadone, palfium and benzodiazepines during a period of imprisonment even led to serious withdrawal fits. In this respect, a notable difference of opinion can be observed between the vast majority of Amsterdam general practitioners and an estimated two-thirds of all prison doctors, who are virtually all GPs appointed part-time to the prison service.

Other cases of temporary cessation of palfium use arose from holidays outside the city. In that situation, too, the withdrawal symptoms were not as bad as expected, or lack of methadone was responsible for the withdrawal problem: "I had too little methadone; after two-and-a-half weeks I felt flu-ish, with cold shivers."

10.5 Summary

There are wide variations in the way in which palfium intoxication is experienced, but the general impression is of a warm, comfortable feeling, which is less intense and less dazing than, and does not last as long as, a heroin-induced 'high'. Approximately one third of the clients were dissatisfied with the effects of palfium. These clients have since (most voluntarily) stopped taking palfium. The high level of satisfaction amongst the group currently receiving palfium can therefore be largely ascribed to self-selection.

The most common negative effect experienced is the absence of the intended effect, a 'high'. In addition, because of the shorter effective period, mild withdrawal symptoms occur more often in the morning than is the case with a combination of methadone and heroin. These can be remedied by an adjustment of the methadone dosage.

No definitive verdict can be given on other side-effects. Given the high co-morbidity within this population, it is difficult to definitively ascribe particular symptoms to the provision of palfium, to the stoppage of other drugs or medication, or to the progressive development of a disease.

Social side effects, such as the harassment or threatening of palfium users by other drug users on the street, or the sale of palfium, are negative aspects which can to a large extent be prevented through intensive supervision and checks.

After ending the palfium treatment, possibly coinciding with an increase in the methadone dosage, the withdrawal symptoms are not generally serious.

One major exception is the forced ending of opiate treatment following imprisonment in a detention centre or prison.

11. Influence of palfium on the use of illegal drugs

11.1 General

In addition to the specific individual treatment agreements, the general goal of the palfium treatment is to reduce the need for heroin, so that its use either stops completely or significantly decreases. Using urine tests, an insight is gained into the stoppage of heroin use. If use decreases, for example from several times per day to several times per week, then the urine tests remain positive. Information over the exact level of reduced consumption can only be ascertained from the statements made by the clients during the survey, in conjunction with their observed social functioning. This section considers the data gathered from he interviews and the urine tests. All the clients have already been dependent upon opiates for a long time, on average 21 years. Apart from two clients with a primary palfium addiction who registered with the GG&GD at the request of their general practitioners, the addiction is to a combination of methadone and heroin. As well as heroin, 90% of the clients also use cocaine. Most of the clients take heroin by 'smoking the dragon' - heating the heroin on tinfoil and inhaling the smoke. Cocaine is also smoked by the majority, in the form of cocaine base (processed cocaine or 'crack'). A minority (36%) took heroin and/or cocaine intravenously before the start of the palfium treatment. A significant proportion of the clients (53%) uses benzodiazepines (soporifics and tranquillizers such as Valium, Seresta, Rohypnol and Temesta), either with or without prescriptions. These substances are regularly used by 36%, whilst 17% take benzodiazepines from time to time, as compared with 10% of the entire Dutch adult population. Ten clients (19%) also consume excessive alcohol (more than 10 units per day).

11.2 Urine tests

As described in section 6.3, weekly urine tests are carried out during the palfium treatment. This is done to check the actual use of the palfium tablets, which is made possible through the addition of a marker to the tablets. But it also provides a qualitative overview of total drug use. On average, the clients took 24 urine tests prior to the palfium treatment (since 1989) and 22 after it began.

As previously mentioned, the test is in a technical sense dichotomous: positive is positive, and it is not possible to evaluate any reduction in use through testing.

* Heroin

Table 8: Development of heroin use



before palfium

after starting palfium


av. pos. %

last pos.

av. pos. %

last pos.

total (n=51)

81%*

84%8

72%*

65%8

continuing (n=29)

85%**

90%8

69%**

62%8

stopped (n=22)

76%

77%

77%

78%

av. pos. %.: average percentage of positive urine tests per person.

last pos.: percentage of clients whose large urine test was positive.

Difference between befare and after starting palfium: *: Wilcoxon signed rank test p < 0.05, ** p < 0.01 ; 8: Sign. test: p<0.05.

The total figures per client show a significant reduction in the average percentage of positive urine tests. Comparison of the final urine test before the start of palfium treatment and the final test after it begin also shows a significant reduction in the number of positive urine samples, from 84% to 65% for the entire client group.

The reduction in use, in the sense of absolutely heroin-free urine tests, is however only seen amongst those clients who were already being treated with palfium in October 1996. Amongst these clients, 90% of the final urine tests from the period before the palfium treatment were positive, whilst during the period of the palfium treatment 62% of their final urine tests were positive. For those people for whom the treatment was successful, therefore, one-third of the final urine tests were negative for heroin.

Amongst those clients who stopped the palfium treatment, 77% and 78% respectively of the final urine tests before and after the treatment began were positive. For these clients the treatment had no effect, at least in terms of this parameter.

Although there is no question of a statistically significant difference, the figures do seem to show that those clients who continued with the palfium treatment used heroin more often before it began than those clients who stopped the treatment. Amongst the first group an average of 85% of the urine tests were positive, whilst amongst the second group the average was 75% (Mann-Whitney, p = 0.08).

The difference in heroin use during the palfium treatment between the ethnically Surinamese and the other clients is notable. The average number of positive urine tests amongst the ethnically Surinamese clients fell from 89% before palfium to 70% during palfium treatment. Amongst the other clients, the reduction was from 79% to 74% (Mann-Whitney, p = 0.05, marg. stat. sign.)

* Cocaine

Table 9: Development of cocaine use



Before palfium

After starting palfium


av. pos. %

last pos.

av. pos. %

last pos.

total (n=51)

70%

75%

68%

67%

continuing (n=29)

74%

79%

66%

66%

stopped (n=22)

65%

68%

68%

68%

av. pos. %.: average percentage of positive urine tests per person.
last pos.: percentage of clients whose large urine test was positive.

Cocaine had at some time been detected in the urine of 98% of the clients during the period before the palfium treatment. Amongst those who reacted well to the palfium treatment, cocaine use declined. The reduction does not indicate that the palfium treatment had a significant influence, in the sense of increasing or decreasing the frequency of cocaine use.

There is a high correlation between the use of cocaine before and after the start of the palfium treatment (r2 = 0.52; p < 0.001). Nine of the 16 clients for whom every urine test during the period prior to the palfium treatment was positive for cocaine also did not provide a single negative urine sample during the period following its start.

* Benzodiazepines

Table 10: Development of benzodiazepine use

  Before palfium   After starting palfium  


av. pos. %

last pos.

av. pos. %

last pos.

total (n=51)

33%

37%

38%

43%

continuing (n=29)

27%

24%

27%

31%

stopped (n=22)

43%

55%

53%

59%

av. pos. %.: average percentage of positive urine tests per person.
last pos.: percentage of clients whose large urine test was positive.

One distinguishing characteristic between those clients who continued the palfium treatment and those who stopped it is their use of benzodiazepines. Amongst those clients still receiving palfium, 24% of the final urine tests before the palfium treatment began were positive for benzodiazepines, whilst amongst those who stopped taking palfium 55% tested positive (Chi2, p<0.05). No significant increase or decrease in the use of benzodiazepines was observed over time during the palfium treatment.

Benzodiazepine users continue the palfium treatment less frequently. The causes of this possibly lie in background characteristics: amongst these clients there probably exists more psychopathology and extreme multiple drug use. One possible background to this is that because of the narcosis resulting from benzodiazepine use, the relatively light palfium 'high' is not really noticed (see section 10.1).

The final urine tests of clients originating from Surinam were positive less often than those of clients not from Surinam; respectively, the figures were 11% and 52% (Chi2, p<0.01). Obviously, the Surinamese clients tend to have limited themselves to the substances with which their addiction originally began, namely heroin and cocaine. The palfium treatment also appears to have been more successful amongst the ethnically Surinamese clients than for the others. The average percentage of positive urine tests fell amongst the Surinamese clients from 89% to 70%, but amongst the other clients only from 77% to 74% (Mann-Whitney, test between percentage differences, p=0.05, marg. stat. sign.).

11.3 Interviews

* Development of heroin and cocaine use

The interviews also indicated that heroin use fell amongst clients who received palfium. Of those clients still using palfium, only two (8%) stated that they were still taking as much heroin as previously; 17 clients (67%) said they were using less heroin (less heroin per day, or heroin on fewer days per month); and six clients said they were no longer or only sporadically using it.



Translation: title=Comparison heroin and cocain use continuing participant palfium treatment ('PB') and abandonees; column heads: nog PB/heroine=still in PB/heroin, uit PB/hero´ne=out of PB/heroin; nog PB/coca´ne=still in PB/cocain, uit PB/coca´ne=out of PB/cocain; row heads: gestopt/zelden=stopped/seldom, minder=less, gelijk=same, meer=more).

These statements could be corroborated by the final urine tests. Of the 14 clients interviewed who had ended the palfium treatment, nine were using as much heroin as before, whilst four said they were using less. One client said his use was sporadic. These results are illustrated graphically in the figure on page 43.

Because of technical limitations, the decreased use claimed could not be corroborated by urine tests. Some clients said that they limited their heroin use to weekends, seeking 'compensation' in heroin if the palfium given to them on the Friday was used up by the Sunday. Such use led to positive urine tests during the subsequent period, as described.

The cocaine use by 15 of the 25 clients interviewed who were still taking palfium had remained unchanged. Seven clients said they were using less cocaine, and one client was using it only sporadically. Two clients said they were using more cocaine.

Of the 14 clients interviewed who had stopped taking palfium, nine (64%) said their cocaine use had remained constant. Two clients (14%) said they had reduced their use, and only one interviewee had stopped using cocaine. Also, two clients (14%) stated that their consumption had increased. This self-reported information varied little from that obtained from the urine tests, with the result being a small difference between the cocaine use of those clients who are still taking palfium and those who have stopped it.

It goes without saying that, given the target group and the professional insight into it built up within the Drugs Department over the previous decades, care needs to be taken in the interpretation of the self-reported developments in use. But there does appear to be reasonable agreement between the answers given and the laboratory results.

The statements of those clients who said that they were no longer or only sporadically using heroin or cocaine could indeed be verified with the aid of urine tests. Moreover, the conclusions drawn based upon the interviews largely agreed with those based upon the urine tests: a decrease in heroin use but not in cocaine use. It also appears that, as far as heroin use is concerned, the reduction is primarily limited to those clients who are still being treated with palfium.

It was notable that cocaine, in particular the base cocaine ('crack') which originally had to be prepared by the user but is now also available 'ready-made', is regarded by the clients themselves as more difficult to control and more 'upsetting' than heroin. This is illustrated by the following remarks: "That ready-made coke makes you crazy, its so compulsive - once you smoke one pipe you can't stop any more; the next day you ask yourself what you've been doing." The compulsive effect of cocaine was demonstrated by one client who had bought several 'rocks' of base cocaine just before the interview. Despite repeated explicit requests not to smoke it, he just could not resist the temptation: he simply had to take it - immediately! Although such behaviour normally leads to serious repercussions for the treatment in the standard practice of the Drugs Department, this exception was to the strict rule was tolerated because of of the importance to the research of the evaluation interview about to be held.

The ready-made base cocaine is widely offered by dealers, but according to the clients is of variable quality: "There's virtually nothing except prepared coke available any more, it's easier. Before, you got the powder and had to prepare it yourself. Then you really got something from it. Now you take a whole lot of it and you hardly notice anything from it." One client had stopped using cocaine as a result: "I've stopped with coke - coke is never enough."

11.4 Interaction between cocaine and heroin use and the influence of palfium

Amongst the palfium clients, opiate addiction is a basic factor and for most the daily heroin 'high' is indispensable. Cocaine, however, is used in various ways and also has various functions. It is often seen as an 'extra': "I use white [cocaine] when I get my money, once a month." Sometimes heroin is used in combination with cocaine, to limit the cocaine's stimulant effect: "I use much less heroin; before, I was shooting up eight times a day and now I'm down to once or twice a week. My coke use has also dropped. But my coke is really more important than the heroin - I use the brown to limit the white." For this purpose, heroin is used intravenously in combination with cocaine (in a form known as >speedballs'). With palfium in such cases, heroin use cannot be reduced completely unless cocaine use also ceases. When buying drugs, cocaine is also associated with heroin, so that a reduction in heroin use can lead to a reduction in cocaine use: "During the palfium, I was using less heroin and so less coke, too. The dealer has both white and brown. If you go for brown, the white is just too tempting."

The fear that users who are supplied with an intoxicant opiate will generally use the money saved to buy more cocaine is unfounded; the interviews indicate that an increase in cocaine use was only observed amongst a small minority (10%): "At first I was using brown daily; I was taking about three grams a week. Now I only use half a gram a week, mostly on Sundays. I do still use white daily - about two-and-a-half grams per week. I do use rather more white since the palfium, so I don't have much money left over."

With 28% of the clients using less cocaine during the palfium treatment, such a reduction was reasonably common.

The urine tests of the 37 clients who had taken at least 10 tests since the start of the palfium treatment and/or in whom cocaine and heroin had been detected since the start of treatment were studied. The question considered was whether a reduction in heroin use is related to the development of cocaine use. A reduction in heroin use was noted in 60% of the group, and a reduction in cocaine use in 54%. The percentage of urine tests which were positive for heroin rose or remained stable at 40%, and for cocaine at 46%.

Table 11:

Cocaine

Heroin

reduced unchanged or increased  

reduced

16 43.2%

6 16.2%

22 59.5%

unchanged or increased

4 10.8%

11 29.7%

15 40.5%


20 54.1%

17 45.9%

37 100%

Of the 22 clients whose heroin use fell, the cocaine use also fell in 16 cases. Amongst these 22 people, the average percentage of urine tests which were positive for cocaine fell from 78% during the period prior to the palfium treatment to 64% after its start.

Of the 15 clients whose heroin use did not fall, the cocaine use of the majority (11 persons) also did not fall. Amongst these 15 clients, the percentage of cocaine-positive urine tests rose slightly, from 76% to 80%.

A greater fall in cocaine use is therefore observed in the group whose heroin use decreased than in the group whose heroin use increased or remained stable (Mann-Whitney, p<0.05).

11.5 Method of use

Amongst the group studied, intravenous use is uncommon. Of the 19 clients who were using intravenously, four have now stopped doing so, and not a single client has started using intravenously: "I really couldn't shoot up any more, because my veins were too bad - it took a long time before I could get a shot in. With palfium I use heroin much less, once every two weeks, but not intravenously any more." Another client: "Since palfium, I've given up shooting up, and since I stopped taking palfium I've only smoked the dragon twice." With the other clients who use intravenously, if their heroin use has declined then their injecting frequency has fallen proportionately: "Before, I was shooting up eight times a day and now I'm down to once or twice a week."

The intravenous use of heroin did not decline for everybody. The 'addiction to the needle' - the usage ritual - is sometimes at least as important as the addition to the heroin. One client, who was in hospital due to AIDS on the observation date, was intravenously taking heroin and cocaine four to seven times a day, despite the palfium treatment. His palfium treatment was ended, and for palliative reasons he was transferred to treatment with intravenously administerable methadone.

12. Commentary

Based upon the results of the trial, palfium treatment appears to be a good addition to the range of opiate treatments. Providing that it is carried out in a tightly-controlled setting with careful prior selection, the treatment is safe for both the individual client and for society. Palfium is no panacea, but it does appear to be a good aid in putting users in a position to better manage their lives. It has its greatest chance of success primarily amongst clients who do not use benzodiazepines and have remained 'faithful' to their original addiction to heroin and cocaine. In practice, these are principally ethnically Surinamese opiate addicts. Homelessness appears to be one explanatory factor for the 'failure' of palfium for a number of clients in this low-threshold treatment programme.

For this reason, the desired results may be expected amongst the group of homeless, ethnically Surinamese chronic 'street' users - if they can be accommodated by the social services in combination with a palfium treatment basis upon a clear treatment and conduct contract.

To conclude, a relatively successful palfium treatment is no permanent substitute for treatment with heroin, especially given the residual character of those still addicted to that drug. After all, as many of the clients themselves put it: "Nothing is like heroin - nothing."


Literature

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