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

Who is this study for? Adult veterans with post-traumatic stress disorder and alcohol use disorder
What treatments are being studied? Oxytocin
Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

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

• Able to provide written informed consent.

• Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder.

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

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

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Stacey Sellers, MS
sellersst@musc.edu
843-792-5807
Backup
Sudie Back, PhD
backs@musc.edu
Time Frame
Start Date: 2021-03-29
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 180
Treatments
Experimental: Oxytocin Treatment Group
Participants will receive 12 weekly sessions of Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE Therapy), plus intranasal Oxytocin.~40-IU dose of Oxytocin self-administered 30 minutes prior to the start of each weekly COPE session.
Active_comparator: Placebo Group
Participants will receive 12 weekly sessions of Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE Therapy), plus placebo (intranasal saline spray).~Intranasal dose of saline spray self-administered 30 minutes prior to the start of each weekly COPE session.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This content was sourced from clinicaltrials.gov