CTN-0159: Randomized, Placebo-Controlled Trial of Bupropion Among Buprenorphine-Stabilized Individuals with Dual Opioid and Stimulant Use Disorder (4thWave) (NIH HEAL Initiative)
Madhukar H. Trivedi, MD
Co-Principal Investigator
University of Texas Southwestern Medical Center
Madhukar.Trivedi@utsouthwestern.edu
Steven Shoptaw, PhD
Co-Principal Investigator
University of California, Los Angeles
sshoptaw@mednet.ucla.edu
Alison Oliveto, PhD
Co-Principal Investigator
University of Arkansas for Medical Sciences
OlivetoAlison@uams.edu
The fourth wave of the opioid crisis involves increasing opioid and stimulant comorbid use. Identifying pharmacologic strategies addressing co-occurring opioid and stimulant use is a critical priority when treating individuals with comorbid opioid and stimulant use disorders. This will be a phase II, 12-week multisite, double-blind, placebo-controlled trial with a two-week baseline period in which adult participants with moderate to severe opioid use disorder and co-occurring methamphetamine and/or cocaine use disorders will be inducted onto extended-release buprenorphine (XR-BUP) prior to randomization. At the end of week 2, participants will be randomized centrally (1:1) to receive bupropion (450 mg/day) or matching placebo for 10 weeks, balancing groups with respect to baseline opioid use, nonmedical stimulant use, and depression rating on the Inventory of Depressive Symptomatology Self-Report (IDS-SR). All participants will receive medication management and manual-guided cognitive behavioral therapy (CBT). Follow-up visits will occur in weeks 13-16. The primary outcome is urine-verified stimulant- and opioid-free response during the final two weeks of treatment.
Funded by the NIH HEAL Initiative®
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