RecruitingPhase 2NCT04523922

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

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


Sponsor

Medical University of South Carolina

Enrollment

180 participants

Start Date

Mar 29, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether oxytocin (a hormone sometimes called the 'bonding hormone') given as a nasal spray can improve the effectiveness of an integrated therapy program for U.S. military veterans who have both alcohol use disorder and PTSD. **You may be eligible if...** - You are a U.S. military veteran, male or female, between 18 and 70 years old - You have been diagnosed with moderate to severe alcohol use disorder - You have been diagnosed with PTSD - You are willing to reduce your drinking and engage in therapy **You may NOT be eligible if...** - You have bipolar disorder or psychotic disorder - You have a serious unstable medical condition - You are currently using opioids or have opioid use disorder requiring medication - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG40 IU Intranasal Oxytocin

40 IU Intranasal Oxytocin self administered 30 minutes prior to each COPE session.

DRUGPlacebo

Placebo (intranasal saline spray) self administered 30 minutes prior to each COPE session.

BEHAVIORALConcurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure

12 weekly sessions of COPE therapy for PTSD and AUD.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT04523922


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