Protocol: NIDA-CTN-0027: Starting Treatment with Agonist Replacement Therapies (START).

Currently in the United States, pharmacological treatment of opioid addiction most commonly consists of replacement therapy with either methadone or buprenorphine/naloxone (bup/nal). Several clinical trials from the NIDA Clinical Trials Network have demonstrated the effectiveness of bup/nal in a variety of treatment settings and populations. Most recently a multi-site, open label, Phase IV study randomized 1269 participants in federally licensed opioid treatment programs to receive either six months of methadone or six months of bup/nal (CTN-0027, “START”).

The primary outcomes of the study focused on parameters of liver function; 731 participants completed the study. Worsening of indices of liver health was rare and did not differ by medication condition. Participants in the bup/nal group had poorer treatment retention than did participants on methadone. Adoption of bup/nal treatment in licensed opioid treatment programs will require additional efforts towards treatment retention.

Related protocols: CTN-0027