NIDA-CTN-0027

This was a randomized, open-label, multi-center, Phase 4 study to assess the changes in liver enzymes related to treatment with buprenorphine/naloxone (BUP/NX) and methadone (MET) in participants entering opioid agonist treatment. Randomization was stratified, within site, according to normal versus abnormal eligibility assessment phase liver tests (LT) and participants received either BUP/NX or MET using a 2:1 allocation ratio. Participants meeting entry criteria were dosed for 24 weeks during the active phase of the study with assessment of liver function and injury at weeks 1, 2, 4, 8, 12, 16, 20, 24 and with follow-up assessments at week 32. A total of 1,269 participants were enrolled across eight sites.