302
Participants
Start Date
September 30, 2011
Primary Completion Date
January 31, 2013
Study Completion Date
March 31, 2013
Buprenorphine + Naltrexone
Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
Placebo + Naltrexone
Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
Bellevue Hospital Center, New York
Albert Einstein College of Medicine - Division of Substance Abuse, The Bronx
Howard University Hospital, Washington D.C.
Atlanta VA Medical Center, Atlanta
Maryhaven, Columbus
South Texas Veterans Health Care System, San Antonio
Addiction Research and Treatment Services (ARTS), Denver
UCLA Integrated Substance Abuse Programs (ISAP), Los Angeles
Bay Area Addiction Research and Treatment (BAART), San Francisco
CODA, Inc., Portland
Recovery Centers of King County (RCKC), Seattle
National Institute on Drug Abuse (NIDA)
NIH
The Emmes Company, LLC
INDUSTRY
University of California, Los Angeles
OTHER