NIDA-CTN-0048

This was a randomized, controlled trial that enrolled 302 cocaine-dependent participants who had either past-year opioid dependence or past-year opioid abuse or past-year opioid use with a history of opioid dependence during the lifetime. Participants were randomized to one of three treatment arms: 1) placebo plus naltrexone, 2) 4mg buprenorphine plus naltrexone, and 3) 16mg buprenorphine plus naltrexone. Participants received 8 weeks of pharmacotherapy, with thrice weekly clinic visits. The primary aim of the study was to compare the number of cocaine use days during the 30-day evaluation period (the final 30 days of active medication administration prior to taper; days 25-54) amongst the treatment groups. The study also evaluated a number of secondary outcome measures.