Active — Not RecruitingPhase 2

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

United States175 participantsStarted 2021-03-29

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

Change in alcohol use

Timeframe: From baseline to week 12 and 3 and 6 month follow ups

Change in PTSD symptom severity - clinician rated

Timeframe: From baseline to week 12 and 3 and 6 month follow ups

Change in PTSD symptom severity - self report

Timeframe: From baseline to week 12 and 3 and 6 month follow ups

Trial details

NCT IDNCT04523922

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More PTSD trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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