Oxytocin to Enhance Integrated Treatment for AUD and PTSD

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

1. Male or female; U.S. military Veteran, any race or ethnicity; aged 18-70 years.

2. Able to provide written informed consent.

3. Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder (assessed via the MINI).

4. Meet DSM-5 diagnostic criteria for current PTSD as assessed by the CAPS-5.

5. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders. Concurrent substance use disorders (e.g., marijuana) are acceptable provided alcohol is the participant's primary substance of choice.

6. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.

Exclusion Criteria:

1. Meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those participants will be referred clinically for services.

2. Participants on psychotropic medications which have been initiated during the past 4 weeks.

3. Acute alcohol withdrawal as indicated by CIWA-Ar scores >8.

4. Pregnancy or breastfeeding for women.

5. For MRI scan component: history of seizures or severe head injury, implanted metal devices or other metal (e.g., shrapnel). These participants will be eligible to enroll in the clinical trial but will not be eligible to participate in the neuroimaging component of the study.

6. Currently enrolled in behavioral treatment for AUD or PTSD.