Portions of these data were presented to the College on Problems of Drug Dependence in Quebec, Canada, on June 11, 2002; the Buprenorphine Consensus Conference in Washington, D.C., on March 7, 2003; and the Annual Meeting of the American Association for the Treatment of Opioid Dependence in Washington, D.C., on April 13, 2003. The contents herein are solely the responsibility of the authors and do not necessarily represent the official views of NIDA.
Bringing Buprenorphine-Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience
Version of Record online: 18 FEB 2010
2004 American Academy of Addiction Psychiatry
The American Journal on Addictions
Volume 13, Issue S1, pages S42–S66, May-June 2004
How to Cite
Amass, L., Ling, W., Freese, T. E., Reiber, C., Annon, J. J., Cohen, A. J., McCarty, D., Reid, M. S., Brown, L. S., Clark, C., Ziedonis, D. M., Krejci, J., Stine, S., Winhusen, T., Brigham, G., Babcock, D., Muir, J. A., Buchan, B. J. and Horton, T. (2004), Bringing Buprenorphine-Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience. The American Journal on Addictions, 13: S42–S66. doi: 10.1080/10550490490440807
- Issue online: 18 FEB 2010
- Version of Record online: 18 FEB 2010
- Received January 5, 2004; accepted January 12, 2004.
In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone®) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/ or medical detoxification for opioid dependence.