Cocaine use reduction with buprenorphine (CURB): rationale, design, and
methodology.
Author(s): Mooney LJ(1), Nielsen S, Saxon A, Hillhouse M, Thomas C, Hasson A, Stablein D,
McCormack J, Lindblad R, Ling W.
Affiliation(s): Author information:
(1)UCLA Integrated Substance Abuse Programs, Los Angeles, CA 90025, USA.
lmooney@mednet.ucla.edu
Publication date & source: 2013, Contemp Clin Trials. , 34(2):196-204
BACKGROUND: Effective medications to treat cocaine dependence have not been
identified. Recent pharmacotherapy trials demonstrate the potential efficacy of
buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The
National Institute on Drug Abuse Clinical Trials Network (CTN) launched the
Cocaine Use Reduction with Buprenorphine (CURB) investigation to examine the
safety and efficacy of sublingual BUP (as Suboxone®) in the presence of
extended-release injectable naltrexone (XR-NTX, as Vivitrol®) for the treatment
of cocaine dependence. This paper describes the design and rationale for this
study.
METHODS: This multi-site, double-blind, placebo-controlled study will randomize
300 participants across 11 sites. Participants must meet the DSM-IV criteria for
cocaine dependence and past or current opioid dependence or abuse. Participants
are inducted onto XR-NTX after self-reporting at least 7 days of abstinence from
opioids and tolerating a naloxone challenge followed by oral naltrexone and are
then randomly assigned to one of three medication conditions (4 mg BUP, 16 mg
BUP, or placebo) for 8 weeks. Participants receive a second injection of XR-NTX 4
weeks after the initial injection, and follow-up visits are scheduled at 1 and 3
months post-treatment. Participants receive weekly cognitive behavioral therapy
(CBT). Recruitment commenced in September, 2011. Enrollment, active medication,
and follow-up phases are ongoing, and recruitment is exceeding targeted
enrollment rates.
CONCLUSIONS: This research using 2 medications will demonstrate whether BUP,
administered in the presence of XR-NTX, reduces cocaine use in adults with
cocaine dependence and opioid use disorders and will demonstrate if XR-NTX
prevents development of physiologic dependence on BUP.
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