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Buprenorphine/Naloxone and Methadone Effects on Laboratory Indices of Liver Health: A Randomized Trial.

Drug and Alcohol Dependence 2013;128(1-2):71-76. [doi: 10.1016/j.drugalcdep.2012.08.002]

Andrew J. Saxon, MD (VA Puget Sound Health Care System, PN Node), Walter Ling, MD (Integrated Substance Abuse Programs, UCLA, PR Node), Maureen Hillhouse, PhD (Integrated Substance Abuse Programs, UCLA, PR Node), Christie Thomas, MPH (Integrated Substance Abuse Programs, UCLA, PR Node), Albert Hasson, MSW (Integrated Substance Abuse Programs, UCLA, PR Node), Alfonso Ang, PhD (Integrated Substance Abuse Programs, UCLA, PR Node), Geetha Doraimani, MS (Integrated Substance Abuse Programs, UCLA, PR Node), Gudaye Tasissa, PhD (Duke Clinical Research Institute, DSC), Yuliya Lokhnygina, PhD, MS (Duke Clinical Research Institute, DSC), Jeffrey D. Leimberger, PhD (Duke Clinical Research Institute, DSC), R. Douglas Bruce, MD, MA (Yale University School of Medicine, NEC Node), John McCarthy, MD (Bi-Valley Medicine Clinic, PR Node), Katharina Wiest, PhD (CODA, Inc., WS Node), Paul McLaughlin, MA (Hartford Dispensary, NEC Node), Richard Bilangi (Connecticut Counseling Center, NEC Node), Allan J. Cohen, MA (Bay Area Addiction Research & Treatment, PR Node), George E. Woody, MD (University of Pennsylvania School of Medicine), Petra Jacobs, MD (Center for the Clinical Trials Network, NIDA).

This is the primary outcomes article for CTN-0027. Buprenorphine/naloxone (BUP) and methadone (MET) are efficacious treatments for opioid dependence, although concerns about a link between BUP and drug-induced hepatitis have been raised. This study, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0027 (Starting Treatment with Agonist Replacement Therapies (START)), was a randomized controlled trial of 1269 opioid-dependent participants seeking treatment at 8 federally licensed opioid treatment programs and followed up for 32 weeks between May 2006 and August 2012. Participants were randomly assigned to receive BUP or MET for 24 weeks. Shift table analyses determined how many evaluable participants moved between categories of low and elevated transaminase levels. Predictors of moving from low to high transaminase levels were identified.

Results determined that changes in transaminase levels did not differ by medication condition. Baseline infection with hepatitis C or B was the only significant predictor of moving from low to high transminase levels; 9 BUP and 15 MET participants showed extreme liver test elevations and were more likely than those without extreme elevations to have seroconverted to both hepatitis B and C during the study, or to use illicit drugs during the first 8 weeks of treatment. MET participants were retained longer than the BUP participants, however the 24-week retention rates for the BUP group in this study were in the range seen in prior studies. In fact, because of its superior safety profile and excellent clinical responses to BUP in previous studies, BUP could be considered a first line treatment agent, with MET reserved for those who do not respond well to BUP.

Conclusions: 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. (Article (Peer-Reviewed), PDF, English, 2013)

Keywords: Buprenorphine/Naloxone | Community health services | CTN primary outcomes | Liver enzymes | Methadone maintenance | Opioid dependence | Pharmacological therapy | Suboxone | Drug and Alcohol Dependence (journal)

Document No: 901, PMID: 22921476, PMCID: PMC3543467.

Submitted by CTN Dissemination Librarians, 8/25/2012.

Ang, Alfonso search
Bilangi, Richard search
Bruce, R. Douglas search mail
Cohen, Allan J. search mail
Doraimani, Geetha search
Hasson, Albert search mail
Hillhouse, Maureen search mail
Jacobs, Petra search mail
Leimberger, Jeffrey D. search
Ling, Walter search mail
Lokhnygina, Yuliya search
McCarthy, John search mail
McLaughlin, Paul search mail
Saxon, Andrew J. search mail
Tasissa, Gudaye search
Thomas, Christie search mail
Wiest, Katharina search mail
Woody, George E. search mail
NIDA-CTN-0027 search www
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