Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience
Department of Psychiatry
Medical Subject Headings
Administration, Sublingual; Adult; 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
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.
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Citation: Am J Addict. 2004;13 Suppl 1:S42-66. Link to article on publisher's site