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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

COPE+OT Trial 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.Check my eligibility

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.See study design

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.

COPE+OT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PTSD symptom severity - clinician rated

Change in PTSD symptom severity - self report

Alcohol Use Disorder

COPE+OT 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,435 Total Patients Enrolled

46 Trials studying Alcoholism

4,925 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

800 Previous Clinical Trials

1,362,817 Total Patients Enrolled

423 Trials studying Alcoholism

985,528 Patients Enrolled for Alcoholism

Sudie Back, PhDPrincipal InvestigatorMedical University of South Carolina

1 Previous Clinical Trials

182 Total Patients Enrolled

1 Trials studying Alcoholism

182 Patients Enrolled for Alcoholism

Media Library

Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure Clinical Trial Eligibility Overview. Trial Name: NCT04523922 — Phase 2

Alcoholism Research Study Groups: Oxytocin Treatment Group, Placebo Group

Alcoholism Clinical Trial 2023: Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure Highlights & Side Effects. Trial Name: NCT04523922 — Phase 2

Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure 2023 Treatment Timeline for Medical Study. Trial Name: NCT04523922 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what types of afflictions is Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure usually applied?

"Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure is employed to control hemorrhage, as well as regulate labour contractions and facilitate childbirth."

Answered by AI

Has the FDA authorized Prolonged Exposure for concurrent treatment of PTSD and substance abuse issues?

"Due to the lack of available clinical data supporting efficacy, Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure was assigned a score of 2 in regards to safety."

Answered by AI

Does the recruitment period for this trial still remain open?

"Affirmative. According to the data presented on clinicaltrials.gov, this medical study is in progress and recruiting participants since its launch on March 29th 2021. 180 people will be accepted across one location through December 16th of this year."

Answered by AI

How many participants are currently involved in this therapeutic program?

"Affirmative. Clinicaltrials.gov reveals that this scientific examination, which was initially posted on March 29th 2021, is currently recruiting patients. 180 people have to be enlisted from one site for the study's completion."

Answered by AI

Is the eligibility criteria for this research study inclusive of individuals over 45 years of age?

"Based on the specified criteria for participation, individuals aged 18 to 70 are eligible. For those under 18, there are 78 clinical trials available and 509 options for people over 65 years old."

Answered by AI

Am I qualified to participate in this research endeavor?

"This research study is seeking 180 individuals aged 18-70 with alcohol drinking behaviors. Furthermore, participants must meet the following criteria: potential mood disorder (excluding bipolar affective disorder), any gender, Veteran status of the U.S. Armed Forces and no particular racial or ethnic background."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

Sudie E. Back 2021. "Oxytocin to Enhance Integrated Treatment for AUD and PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04523922.

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