Heroïne en methadon op medisch voorschrift voor chronisch, therapieresistente heroïneverslaafden: twee gerandomiseerde studies

To investigate the effectiveness of medically co-prescribed heroin to chronic, treatment-resistant heroin dependent patients in methadone maintenance treatment programmes.

Design

Randomised, open, multi-centre (n = 6).

Method

Two trials, one with inhalable heroin (n = 375) and one with injectable heroin (n = 174), were conducted, comparing a 12-month treatment of heroin (max. 1000 mg per day) plus orally administered methadone (max. 150 mg per day) versus just methadone (max. 150 mg per day). The trial with inhalable heroin also incorporated a group (n = 119) which received six months of medical heroin; this group is not included in this paper. The methadone was supplied 2-7 times per week for daily use and the heroin was offered 3 times per day, 7 days per week. A similar level of psychosocial care was available in the trial groups. The main outcome criterion was a dichotomous, multi-domain response index, including validated indicators of physical health, mental status, social functioning, and substance use.

Results

The 12-month outcome data were available for 94 of all 549 randomised patients. Using an intention-to-treat analysis, 12-month treatment with heroin plus methadone was significantly more effective than treatment with methadone alone in the trial with injectable heroin (response rate: 57 versus 32; difference 25; 95-CI: 10-40) as well as in the trial with inhalable heroin (response rate: 48 versus 25; difference: 23; 95-CI: 11-34). Discontinuation of the co-prescribed heroin after 12 months resulted in a considerable deterioration in the situation of the 83-84 of patients who had responded well to the co-prescribed heroin. The incidence of serious adverse events was low and was similar across treatment groups.

Conclusion

Supervised prescription of heroin in combination with methadone is safe and more effective than methadone alone in reducing the physical, mental and social problems of chronic, treatment-resistant heroin dependent patients.