PROTOCOL NIDA-CTN-0048


Cocaine Use Reduction with Buprenorphine (CURB)

Walter Ling, MD
Lead Investigator
Director, Integrated Substance Abuse Programs, UCLA
lwalter@ix.netcom.com

Andrew Saxon, MD
Co-Lead Investigator

Director, Addiction Treatment Center
Veterans Affairs Puget Sound Health Care System
andrew.saxon@va.gov

Larissa Mooney, MD
Co-Lead Investigator
Integrated Substance Abuse Programs, UCLA
lmooney@mednet.ucla.edu

The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence. Eleven CTP study sites will enroll 300 cocaine-dependent participants who also meet criteria for either past-year opioid dependence or past-year opioid abuse, or past-year opioid use with a history of opioid dependence during the lifetime.

CTN-0048 Study Protocol

PRIMARY FINDINGS

Group differences were not found with the planned primary outcome that assessed UDS-corrected self-reported cocaine use during the last 4 weeks of the treatment period. Longitudinal analysis of UDS data alone during the evaluation period using generalized estimating equations (GEE) found a statistically significant reduction in methamphetamine use in the BUP 16-treated group and the PLB group (p=0.030). Difference across groups were not found for adherence, retention, or adverse events during the evaluation period.

Primary Outcomes Article: Ling W, et al. Buprenorphine-Naloxone plus Naltrexone for the Treatment of Cocaine Dependence: The Cocaine Use Reduction with Buprenorphine (CURB) Study. Addiction 2016;111(8):1416-1427. [get article]

RELATED STUDIES
RELATED RESOURCES

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Publications about CTN-0048

Study data from NIDA Data Share

ClinicalTrials.gov (NCT01402492)

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.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 10/2011 -- http://ctndisseminationlibrary.org/protocols/ctn0048.htm
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