Buprenorphine/naloxone and methadone effects on laboratory indices of liver health: A randomized trial.
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.
Related protocols: CTN-0027