Using oxytocin to improve treatment for veterans with PTSD and alcohol use disorder

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

This study tests if adding oxytocin to a therapy program can help veterans with PTSD and alcohol use disorder feel better compared to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Medical University of South Carolina (other)
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT04523922 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of oxytocin compared to a placebo in reducing symptoms of alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) among veterans undergoing a specific therapy called COPE. The COPE therapy integrates cognitive-behavioral techniques for AUD with prolonged exposure therapy for PTSD. Participants will undergo functional magnetic resonance imaging (fMRI) before and after treatment to assess neurobiological changes. The study seeks to enhance treatment outcomes and retention rates for veterans suffering from these co-occurring conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are U.S. military veterans aged 18-70 who have moderate to severe alcohol use disorder and PTSD.

Not a fit: Patients with a history of psychotic or bipolar disorders, or those with current suicidal or homicidal ideation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment outcomes for veterans suffering from both PTSD and alcohol use disorder.

How similar studies have performed: Previous studies have shown promise in using oxytocin to enhance psychosocial treatments for similar conditions, indicating potential for success in this approach.

Eligibility 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.
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.

Where this trial is running

Charleston, South Carolina

• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Sudie Back, PhD — Medical University of South Carolina
• Study coordinator: Stacey Sellers, MS

Conditions: PTSD, Alcohol Use Disorder