A placebo‐controlled study of high dose buprenorphine in opiate dependents waiting for medication‐assisted rehabilitation in Oslo, Norway

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Abstract
Aims To evaluate whether buprenorphine, even without additional control and psychosocial treatment and support, alleviates the problems faced by patients waiting for medication assisted rehabilitation (MAR). Design A randomized, double‐blind, 12‐week study of Subutex® versus placebo without additional support as an interim therapy. Participants One hundred and six patients, 70 males and 36 females, waiting for MAR in Oslo. The average age was 38 years with an average history of heroin use of 20 years. Fifty‐five patients were assigned to buprenorphine and 51 to a placebo. Intervention Subutex® or placebo sublingual tablets were given under supervision in a daily dose of 16 mg with the exception of a double dose on Saturday and no dose on Sunday. Measurement Retention, compliance, self‐reported drug‐abuse, wellbeing and mental health. Findings The average number of days of participation was significantly higher in the buprenorphine group, 42 (median: 29) compared to 14 (median: 11) for the placebo group (P < 0.001). The retention of patients after 12 weeks was 16 patients in the buprenorphine group and one patient in the placebo group. The buprenorphine group had a larger decrease in reported opioid use (p < 0.001) and in reported use of other drugs, tablets and alcohol abuse (p < 0.01). The group also showed a stronger increase in wellbeing (p < 0.01) and life satisfaction (p < 0.05). None of the participants died. Conclusion The patients waiting for MAR benefited significantly from the buprenorphine as an interim therapy according to retention, self‐reported use of drugs and wellbeing. However, the patients had difficulties in remaining in treatment over time without psychosocial support.