Addictions, Drug & Alcohol Institute

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

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.

Part of the National Institute on Drug Abuse Clinical Trials Network. The Alcohol & Drug Abuse Institute serves as the Regional Research and Training Center (RRTC) of the Pacific Northwest Node, which participated in this protocol.


Walter Ling, PhD Lead Investigator (UCLA)

Project Staff

Mary Hatch-Maillette, PhD

Fund Information

National Institute on Drug Abuse (NIDA)
Start: April 2006
End: August 2010
Status: completed

Project Site

CTN Dissemination Library protocol page for CTN-0027

Project Results

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.

Citation: 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. [free online]