In essence, it is a regular trial of a new treatment. Half would be drawn from volunteers currently receiving methadone treatment, who would prefer the expanded treatment option, and half from volunteers who have dropped out of methadone treatment. Equal numbers of men and women would be included from each of these groups. All could change treatments at will, within the limits of medical safety. The first pilot study would also allow investigation of the pharmacokinetics and psychopharmacology of diacetylmorphine, especially effects on driving skills.
Stability is a key issue for the first pilot study.
Stabilised consumption within a defined therapeutic range was identified as a criterion for effective maintenance treatment by a meeting of experts on drug substitution organised by the World Health Organization in May 1995. Participants in the proposed trial would be able to attend the clinic to inject heroin up to three times a day. In contrast to the first pilot study, half the participants would be allocated to the choice of treatment options and half to oral methadone alone. A full-scale randomised controlled trial is the standard and most rigorous way to test a new treatment option. However, before launching such a full-scale trial, it is necessary to test whether it is practicable for dependent drug users.