Yale University

Unobserved versus observed office buprenorphine/naloxone induction: a pilot randomized clinical trial.

TitleUnobserved versus observed office buprenorphine/naloxone induction: a pilot randomized clinical trial.
Publication TypeJournal Article
Year of Publication2010
AuthorsGunderson, Erik W., Xin-Qun Wang, David A. Fiellin, Benjamin Bryan, and Frances R. Levin
JournalAddictive behaviors
Date Published2010 May
KeywordsAdolescent, Adult, Aged, Ambulatory Care, Buprenorphine, Directly Observed Therapy, Female, Humans, Male, Middle Aged, Naloxone, Narcotic Antagonists, New York, Opioid-Related Disorders, Physician's Practice Patterns, Pilot Projects, Primary Health Care, Substance Withdrawal Syndrome, Treatment Outcome, Young Adult
AbstractPhysician adoption of buprenorphine treatment of opioid dependence may be limited in part by concerns regarding the induction process. Although national guidelines recommend observed induction, some physicians utilize unobserved induction outside the office. The aim of this pilot randomized clinical trial was to assess preliminary safety and effectiveness of unobserved versus observed office buprenorphine/naloxone induction among patients entering a 12-week primary care maintenance study. Participants (N=20) with DSM-IV opioid dependence were randomly assigned to unobserved or office induction, stratifying by past buprenorphine use. All patients received verbal and written instructions. A withdrawal scale was used during initiation and to monitor treatment response. Clinic visits occurred weekly for 4 weeks then decreased to monthly. The primary outcome, successful induction one week after the initial clinic visit, was defined as retention in buprenorphine/naloxone treatment and being withdrawal free. Secondary outcomes included prolonged withdrawal beyond 2 days after medication initiation and stabilization at week 4, defined as being in treatment without illicit opioid use for the preceding 2 weeks. Outcome results were similar in the two groups: 6/10 (60%) successfully inducted in each group, 3/10 (30%) experienced prolonged withdrawal, and 4/10 (40%) stabilized by week 4. These pilot study results suggest comparable safety and effectiveness of unobserved and office induction and point toward utilization of non-inferiority design during future definitive protocol development. By addressing an important barrier for physician adoption, further validation of the unobserved buprenorphine induction method will hopefully lead to increased availability of effective opioid dependence treatment.
Alternate JournalAddict Behav

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