This was a randomized outpatient study for treatment-seeking participants dependent on prescription opioid analgesics. The primary objective was to determine whether the addition of individual drug counseling to the prescription of buprenorphine/naloxone (Bup/Nx) and Standard Medical Management (SMM) improves outcome. Participants were randomized at the beginning of each of two phases to receive BUP/NX paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual counseling). Six hundred and fifty three participants were randomized into Phase 1, and 360 participants were randomized into Phase 2.
625a0b15e2cf8e6c627d57cb2a6c88fd NCT00316277
Roger D. Weiss, M.D.
McLean Hospital
115 Mill Street, Belmont, MA, 02478, US
Walter Ling, M.D.
Director
Integrated Substance Abuse Programs
University of California, Los Angeles
11075 Santa Monica Boulevard, Suite 200, Los Angeles, CA, 90025, US
CTN-0030 DSMB-0030
Participating Sites
- Chestnut Ridge Center, West Virginia
- San Francisco General Hospital Division of Substance Abuse and Addiction Medicine (SFGH - DSAAM) , California
- Bellevue Hospital Center , New York
- St. Luke's Roosevelt Hospital Center, New York
- McLean Hospital , Massachusetts
- ADAPT, Inc., Oregon
- Providence Regional Medical Center, Behavioral Health Services, Washington
- Integrated Substance Abuse Programs , California
- Behavioral Health Services of Pickens County, South Carolina
- East Indiana Clinic , Indiana
completed