Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience
Authors
Amass, LeslieLing, Walter
Freese, Thomas E.
Reiber, Chris
Annon, Jeffrey J.
Cohen, Allan J.
McCarty, Dennis
Reid, Malcolm S.
Brown, Lawrence S.
Clark, Cynthia
Ziedonis, Douglas M.
Krejci, Jonathan
Stine, Susan
Winhusen, Theresa
Brigham, Greg
Babcock, Dean
Muir, Joan A.
Buchan, Betty J.
Horton, Terry
UMass Chan Affiliations
Department of PsychiatryDocument Type
Journal ArticlePublication Date
2004-06-19Keywords
Administration, SublingualAdult
Buprenorphine
Community Health Services
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Approval
Drug Therapy, Combination
Humans
Male
Middle Aged
Multicenter Studies as Topic
Naloxone
Narcotic Antagonists
Narcotics
National Institutes of Health (U.S.)
Opioid-Related Disorders
Randomized Controlled Trials as Topic
Rehabilitation Centers
Substance Withdrawal Syndrome
Time Factors
United States
Psychiatry
Metadata
Show full item recordAbstract
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 16 mg 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.Source
Am J Addict. 2004;13 Suppl 1:S42-66. Link to article on publisher's siteDOI
10.1080/10550490490440807Permanent Link to this Item
http://hdl.handle.net/20.500.14038/45662PubMed ID
15204675Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1080/10550490490440807