The Present proposal aims to establish a demonstration research project to reduce the spread of AIDS by improving treatment for intravenous drug abuse. The safety and efficacy of buprenorphine, a novel and promising new treatment, will be evaluated in 200 heroin addicts who are unwilling to accept treatment with methadone maintenance or enter a residential therapeutic community. They will represent two distinct populations at risk: 1) detoxified heroin addicts awaiting discharge from a VA hospital, who will be seen in the outpatient psychiatric clinic of a university hospital (N=100). Subjects will be stabilized on buprenorphine during the first 4 weeks of treatment and then maintained for 16 weeks on the lowest dose that blocks heroin craving and use. Subjects who use heroin will be rated as non-responders and terminated from buprenorphine. To determine the efficacy of buprenorphine, 60 opiate-free subjects at 16 weeks (responders) will be entered in a randomly assigned, placebo controlled, double-blind, 10 week discontinuation trial. Subjects will either: 1) continue to receive buprenorphine; or 2) have buprenorphine withdrawn at 7 months, unless approved for longer use by FDA. Subjects will receive counseling geared to stopping both IV drug use and sexual behaviors which increase the risk of HIV infection. The 60 16-week responders will be seen monthly until treatment month 12 for counseling and to obtain follow-up information. Results of the study will help to develop effective AIDS reduction strategies for an undertreated subgroup of heroin addicts. Demographic and psychosocial variables will be used to assess prognostic indicators for each of two outcome groups: those who relapse to heroin and those who remain heroin free. If results show buprenorphine to be effective and safe, it would support the idea of establishing a model buprenorphine treatment program which could be emulated by others.
