PROTOCOL NIDA-CTN-0027


Starting Treatment with Agonist Replacement Therapies (START)

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

The CTN participates with the Division of Pharmacotherapies & Medical Consequences of Drug Abuse (DPMCDA) on a multi-centered trial to compare the effect of buprenorphine/naloxone (Bup/Nx) and methadone (MET) on liver function.  This is a randomized, open-label, multi-center, Phase 4 study in participants entering opioid agonist treatment programs at community centers (methadone centers) throughout the country.  The trial started in April 2006.  Participants will be randomized until at least 300 evaluable participants are be available in both the Bup/Nx and MET study arms.  The study will randomize approximately 1200 subjects and is being implemented in 8 sites across 6 Nodes.

CTN-0027 Study Protocol

PRIMARY FINDINGS

This study demonstrated no evidence of liver damage during the initial 6 months of treatment with either BUP or MET, providing further encouragement to physicians to use buprenorphine as an effective treatment option for opioid addiction.

Primary Outcomes Article: Saxon A, et al. Buprenorphine/Naloxone and Methadone Effects on Laboratory Indices of Liver Health: A Randomized Trial. Drug and Alcohol Dependence 2013;128(1-2):71-76. [get article]

RELATED STUDIES
RELATED RESOURCES

snowflake

Publications about CTN-0027

Study data from NIDA Data Share

ClinicalTrials.gov study description


NODES & CTPs SEARCH LINK
Pacific Region (Lead) search www
Bay Area Addiction Research and Treatment Inc. search
Matrix Institute search
Western States(Co-Lead) search www
(formerly California/Arizona) search www
(formerly Oregon/Hawaii) search www
Bi-Valley Medical Clinic, Inc. search
CODA, Inc. search
Delaware Valley search www
Northeast Treatment Center search
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Connecticut Counseling Centers, Inc. search
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Evergreen Treatment Services search
OTHER RESOURCES
NIDA protocol page www

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 5/2013 -- http://ctndisseminationlibrary.org/protocols/ctn0027.htm
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