Controlled, randomized trial in maintenance treatment of intravenous buprenorphine dependence with naltrexone, methadone or buprenorphine: a novel study

Abstract

Aims: To test the effect of a 50-mg day-1 dose of naltrexone in the maintenance treatment of intravenous-buprenorphine dependence in comparison with a 50-mg day-1 dose of methadone and also a 5-mg day-1 dose of buprenorphine over a 24-week treatment period.

Participants: Two hundred and four intravenous-buprenorphine-dependent patients who met the DSM-IV criteria for opioid dependence were randomized to three equal groups and were treated in a clinic in Iran where they were also offered a weekly 0.5-h counselling session, in 2002.

Findings: The mean age was 31.2 years (range 17-53). The majority [63.2%] was between 20 and 34 years of age. The educational level of most of them [55.4%] was between 6 and 12 years of study. Completion rates by groups were 83.8% for the 50-mg dose methadone group, 58.8% for the 5-mg dose buprenorphine group and 20.6% for the 50-mg dose naltrexone group (P = 0.000). Retention in the 50-mg methadone group was significantly better than in the 5-mg dose buprenorphine group (P = 0.001) and the 50-mg dose naltrexone group (P = 0.000). Retention in the 5-mg buprenorphine group was significantly better than in the 50-mg naltrexone dose group (P = 0.000).

Conclusions: Evaluation of the Iranian experience on this subject may be useful for other countries.