A multi-center randomized trial of buprenorphine-naloxone versus clonidine for opioid detoxification: Findings from the National Institute on Drug Abuse Clinical Trials Network.

AIMS: The clinical effectiveness of buprenorphine-naloxone (bup-nx) and clonidine for opioid detoxification in inpatient and outpatient community treatment programs was investigated in the first studies of the National Institute of Drug Abuse Clinical Trials Network.

DESIGN: DSM-IV-diagnosed opioid-dependent individuals seeking short-term treatment were randomly assigned, in a 2:1 ratio favoring bup-nx, to a 13-day detoxification using bup-nx or clonidine.

METHODS: A total of 113 inpatients (77 bup-nx, 36 clonidine) and 231 outpatients (157 bup-nx, 74 clonidine) participated. Supportive interventions included appropriate ancillary medications and standard counseling procedures defined as the proportion of participants in each condition who were both retained in the study for the entire duration and provided an opioid-free urine sample on the last day of clinic attendance. Secondary outcome measures included use of ancillary medications, number of side effects reported and withdrawal and craving ratings.

FINDINGS: A total of 59 of the 77 (77%) inpatients assigned to the bup-nx condition achieved the treatment success criterion compared to 8 of the 36 (22%) assigned to clonidine, whereas 46 of the 157 (29%) outpatients assigned to the bup-nx condition achieved the treatment success criterion, compared to 74 (5%) assigned to clonidine.

CONCLUSIONS: The benefits of bup-nx for opioid detoxification are supported and illustrate important ways in which clinical research can be conducted in community treatment programs.

Correction published in Addiction 2006;101(9):1374 names the members of the Buprenorphine Study Protocol Group Steering Committee as follows: Walter Ling, Joan Muir-Malcolm, Eugene Somoza, Edward Nunes, Charles Shuster, John Rotrosen, Dennis McCarty, George Woody, Nancy Waite-O’Brien, Debbie Orr, Greg Brigham, Betty Buchan, Terry Horton, Susan Stine, Steven Ruth, Larry Brown, Robert Maslansky, David Smith, Brad Anderson, Steven Fekete, and Douglas Ziedonis. It also adds Susan M. Stine from Wayne State University to the list of acknowledgements.

Related protocols: CTN-0001, CTN-0002