SoberRecovery - Drug Treatment - Randomized trial of Heroin maintenance programme for failed addicts

Objective: To assess an experimental heroin protection programme.

Design: Randomized trial.

Setting: Outpatient clinic in Geneva, Switzerland.

Subjects: Socially marginalized heroin addicts and in poor health and had failed in at least two previous drug treatments were recruited.

Intervention: Patients in the experimental programme (n = 27) received intravenous heroin and other health and psychosocial services. Control patients (n = 24) received any other conventional drug treatment (usually methadone maintenance). Main outcome measures: Self reported drug use, health status (SF-36), and social functioning.

Results: 25 experimental patients completed 6 months in the programme, receiving a median of 480 mg of heroin daily. One experimental subject and 10 control subjects still used street heroin daily at follow up (difference 44%; 95% confidence interval 16% to 71%). Health status scores that improved significantly more in experimental subjects were mental health (0.58 SD; 0.07 to 1.10), role limitations due to emotional problems (0.95 SD; 0.11 to 1.79), and social functioning (0.65 SD; 0.03 to 1.26). Experimental subjects also significantly reduced their illegal income and drug expenses and committed fewer drug and property related offences. There were no benefits in terms of work, housing situation, somatic health status, and use of other drugs. Unexpectedly, only nine (38%) control subjects entered the heroin maintenance programme at follow up.

Conclusions: A heroin maintenance programme is a feasible and clinically effective treatment for heroin users who fail in conventional drug treatment programmes. Even in this population, however, another attempt at methadone maintenance may be successful and help the patient to stop using injectable opioids.

Introduction:

Many harmful consequences of heroin use stem from the illegal status of street drugs. [1-3] Drug substitution programmes may alleviate these consequences,[4] but not all addicts benefit: many continue using street drugs, others drop out, others never enroll. Addicts may fail in oral substitution programmes because they need the "high" caused by heroin injection or the ritual of preparing and injecting the drug. Programmes which provide intravenous heroin may reach such addicts. [5-12] In Switzerland several programmes involving provision of intravenous opiates were started in 1992-5. [13 14] Most were evaluated in a before and after design. Only the Geneva heroin maintenance programme was conceived as a randomized trial: eligible addicts were randomized either to immediate admission or to a 6 month waiting list during which time they could receive any other available drug treatment. The research question was whether the experimental programme would improve participants' illegal drug use, health, and social functioning.

Methods:

Study design and sample:

This randomized trial compared outcomes at 6 months in patients allocated to immediate versus delayed admission to the heroin maintenance programme. The planned sample size was two groups of 40 patients. Programme and study procedures were approved by ethics committees in Geneva and Berne. Eligibility criteria were residence in the canton of Geneva since June 1994, age [is greater than or equal to] 20 years, addiction to intravenous heroin for [is greater than or equal to] 2 years, daily consumption of opiates, social distress or poor health or both, due to drug use, two or more previous unsuccessful attempts at drug treatment, participation in evaluation, and giving up driving on starting heroin maintenance. Information about the programme was disseminated through drug abuse treatment centers. Interested people were screened on the telephone by a psychiatrist (FG), and those who seemed eligible were invited to an initial visit. During this visit the psychiatrist confirmed the patient's eligibility, explained programme procedures, obtained informed consent, performed the baseline assessment, and allocated the patient to either immediate or delayed admission by using computer generated random numbers placed in sealed envelopes.

Experimental programme:

The programme clinic was established in September 1995 by the division of substance abuse, Geneva University Hospitals, in central Geneva. Staff included a psychiatrist, an internist, a social worker, five nurses, and a secretary. Patients attended usually three times daily. The dose of heroin was established by the psychiatrist on the basis of patients' needs. Patients were instructed in safe intravenous injection practices and could inject the drug themselves. After the injection patients were observed for about 30 minutes. If a patient was intoxicated on arrival the usual dose was halved. Oral opiates (methadone or morphine sulphate) were introduced whenever patients wanted only one or two injections a day or if they had to travel. Benzodiazepines addicted patients received clorazepate substitution treatment; psychological counseling, HIV prevention counseling, social and legal support services, and somatic primary care are provided for all patients.