Status:
RECRUITING
Oxytocin to Enhance Integrated Treatment for AUD and PTSD
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
PTSD
Alcohol Use Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 stre...
Detailed Description
Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur and are associated with significant morbidity, mortality, and health care expenditures. Military Veterans are at...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Participants on psychotropic medications which have been initiated during the past 4 weeks.
- Acute alcohol withdrawal as indicated by CIWA-Ar scores \>8.
- Pregnancy or breastfeeding for women.
- 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.
- Currently enrolled in behavioral treatment for AUD or PTSD.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04523922
Start Date
March 29 2021
End Date
December 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29401