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Oxytocin + COPE Therapy for Alcoholism and PTSD (COPE+OT Trial)

Phase 2

Recruiting

Led By Sudie Back, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Pregnancy or breastfeeding for women

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 12 and 3 and 6 month follow ups

Summary

This trial will compare oxytocin to a placebo in reducing symptoms of alcohol use disorder and post-traumatic stress disorder in veterans receiving COPE therapy. Brain scans will be used to examine potential mechanisms of change.

Who is the study for?

This trial is for U.S. military Veterans aged 18-70 with moderate to severe alcohol use disorder (AUD) and PTSD, who are stable on any psychotropic meds for at least 4 weeks. It's not for those with bipolar disorders, current suicidal thoughts, acute alcohol withdrawal, pregnant or breastfeeding women, or anyone currently in AUD or PTSD therapy.

What is being tested?

The study tests if oxytocin can help reduce symptoms of AUD and PTSD better than a placebo in Veterans undergoing COPE therapy. Participants will also undergo brain scans before and after treatment to see how the therapy works.

What are the potential side effects?

While specific side effects aren't listed here, intranasal oxytocin could potentially cause nasal irritation or discomfort, headaches, changes in heart rate/blood pressure, emotional changes or reactions at the site of administration.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have a history of or currently have severe mental health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 12 and 3 and 6 month follow ups

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 12 and 3 and 6 month follow ups

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12 and 3 and 6 month follow ups for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PTSD symptom severity - clinician rated

Change in PTSD symptom severity - self report

Alcohol Use Disorder

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Oxytocin Treatment GroupExperimental Treatment2 Interventions

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.

Group II: Placebo GroupActive Control2 Interventions

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.

0 / 2Eligibility criteria met