Oxytocin to Enhance Integrated Treatment for AUD and PTSD

Description

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.

Conditions

PTSD, Alcohol Use Disorder

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Study Overview

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Study Details

Study overview

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.

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

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

Condition
PTSD
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical University of South Carolina,

Sudie Back, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2026-01-01