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

Yih-Ing Hser, PhD
Walter Ling, MD
Co-Lead Investigators
Integrated Substance Abuse Programs, UCLA

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.

Primary Findings

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.

Primary Outcomes Article: 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. [get article]

    Node Involvement

    Lead Node(s):

  • Pacific Region Node
  • New England Consortium

  • All Participating Nodes:

  • Delaware Valley Node
  • New England Consortium
  • Pacific Northwest Node
  • Pacific Region Node
  • Western States Node