Addictions, Drug & Alcohol Institute

NIDA CTN-0050: Long-Term Follow-Up of START Patients

No studies to date have examined the longer-term effects of Suboxone versus methadone after treatment termination.  This project will assess the longer-term outcomes of the large sample of opioid-dependent patients randomly assigned, in the START Study (CTN-0027), to receive Suboxone or methadone for a (planned) six to eight months of treatment.  The study team will conduct personal interviews of START participants, approximately 3 to 5 years post-admission, supplemented by (electronic) medical and other records as available.  The results will have important implications for optimizing maintenance treatment for opioid dependence.  The specific aims of the project are as follows: (1) To determine longer-term outcomes of Suboxone versus methadone treatment received in the START Study; (2) To investigate patient and treatment factors associated with post-START treatment access, utilization, and outcomes; (3) To explore other correlates of long-term outcomes among START participants.

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.


Yih-Ing Hser, PhD Co-Lead Investigator (UCLA)
Walter Ling, MD Co-Lead Investigator (UCLA)

Project Staff

Mary Hatch-Maillette, PhD

Fund Information

National Institute on Drug Abuse (NIDA)
Start: September 2010
End: August 2016
Status: completed

Project Site

CTN Dissemination Library protocol page for CTN-0050

Project Results

Analyses revealed no difference in mortality between the two randomized conditions, with 23 (3.6%) of 630 participants randomized to buprenorphine having died, versus 26 (5.8%) of 450 randomized to methadone. Opioid use at follow-up was higher among participants randomized to buprenorphine relative to methadone (42.8% vs. 31.7% positive opioid urine specimens; 5.8 days vs. 4.4 days of past 30-day heroin use). Opioid use over the follow-up period by randomization condition was also significant, mostly due to less treatment participation among participants randomized to buprenorphine. Less opioid use was associated with both buprenorphine and methadone treatment (relative to no treatment); no difference was found between the two treatments.

Citation: Hser Y, Evans E, Huang D, et al. Long-Term Outcomes After Randomization to Buprenorphine/Naloxone Versus Methadone in a Multi-Site Trial. Addiction 2016;111(4):695-705. [free online]