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ACTIVE NOT RECRUITING
NCT04523922
PHASE2

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

Sponsor: Medical University of South Carolina

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.

Official title: Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

175

Start Date

2021-03-29

Completion Date

2026-12-01

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

40 IU Intranasal Oxytocin

40 IU Intranasal Oxytocin self administered 30 minutes prior to each COPE session.

DRUG

Placebo

Placebo (intranasal saline spray) self administered 30 minutes prior to each COPE session.

BEHAVIORAL

Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure

12 weekly sessions of COPE therapy for PTSD and AUD.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States