Clinical Trial

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

Study acronym: COPE+OT
Completed Phase 2
View on ClinicalTrials.gov →
Summary
The primary objective of the proposed Stage II study is to examine the efficacy of oxytocin (OT) as compared to placebo in reducing (1) alcohol use disorder (AUD) symptoms, and (2) post-traumatic stress disorder (PTSD) symptoms among Veterans receiving COPE therapy (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure). To evaluate purported neurobiological mechanisms of change, we will employ functional magnetic resonance imaging (fMRI) at pre- and post-treatment.
Protocol Amendment History 5 changes
critical Trial completed 2026-07-28
notable Primary completion moved earlier: 2026-06-01 -> 2026-04-13 2026-07-28
minor Completion moved earlier: 2026-12-01 -> 2026-04-13 2026-07-28
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-10
notable Primary completion pushed: 2026-04-01 -> 2026-06-01 2026-04-10
Trial Details
NCT Number NCT04523922
Lead Sponsor Medical University of South Carolina
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions PTSD, Alcohol Use Disorder
Enrollment 175 participants
Start Date 2021-03-29
Primary Completion 2026-04-13 (estimated)
Study Completion 2026-04-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-27