PROTOCOL NIDA-CTN-0003


Suboxone (Buprenorphine / Naloxone) Taper: A Comparison of Taper Schedules

Walter Ling, MD
Lead Investigator

Integrated Substance Abuse Programs
University of California Los Angeles
lwalter@ix.netcom.com

This study was undertaken to compare, in an outpatient setting, the relative advantage of two Suboxone® (Bup/Nx) tapering schedules (one rapid and one gradual) following four weeks of Suboxone® stabilization, as reflected by the proportion of participants providing opiate free urines at the end of the taper regimen.  In total, 516 participants were randomized to one of two taper schedules, either 7 days or 28 days.  The reason for conducting this study was not to advocate for short-term treatment, but to determine the relative ease of using a more rapid vs. a gradual taper should someone need to discontinue Bup/Nx.
CTN-0003 Study Protocol

PRIMARY FINDINGS

There appears to be no advantage in prolonging the duration of the taper for individuals terminating Bup/Nx therapy for opioid dependence.  At the end of the taper, 44% of the 7-day taper group (n=255) provided opioid-free urine specimens compared to 30% of the 28-day taper group (n=261; P=0.0007).  There were no differences at the 1-month and 3-month follow-ups (7-day=18% and 12%; 28-day = 18% and 13%, 1 month and 3 months, respectively).

Primary Outcomes Article: Ling W, et al. Buprenorphine tapering schedule and illicit opioid use. Addiction 2009;104:256-265. [get article]

RELATED RESOURCES

Publications about CTN-0003

Study data from NIDA Data Share

Project newsletter: Extra Edition! (single issue, 2006)

ClinicalTrials.gov (NCT00078117)

NIDA protocol page


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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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Updated 2/2011 -- http://ctndisseminationlibrary.org/protocols/ctn0003.htm
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