RECRUITING

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-29

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04523922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female; U.S. military Veteran, any race or ethnicity; aged 18-70 years. 2. Able to provide written informed consent. 3. Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder. 4. Meet DSM-5 diagnostic criteria for current PTSD as assessed by the CAPS-5. 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. 6. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.	1. 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. 2. Participants on psychotropic medications which have been initiated during the past 4 weeks. 3. Acute alcohol withdrawal as indicated by CIWA-Ar scores \>8. 4. Pregnancy or breastfeeding for women. 5. 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. 6. Currently enrolled in behavioral treatment for AUD or PTSD.

Inclusion Criteria

Exclusion Criteria

1. Male or female; U.S. military Veteran, any race or ethnicity; aged 18-70 years.
2. Able to provide written informed consent.
3. Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder.
4. Meet DSM-5 diagnostic criteria for current PTSD as assessed by the CAPS-5.
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.
6. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.

1. 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.
2. Participants on psychotropic medications which have been initiated during the past 4 weeks.
3. Acute alcohol withdrawal as indicated by CIWA-Ar scores \>8.
4. Pregnancy or breastfeeding for women.
5. 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.
6. Currently enrolled in behavioral treatment for AUD or PTSD.

Contacts and Locations

Study Contact

Stacey Sellers, MS

CONTACT

843-792-5807

sellersst@musc.edu

Sudie Back, PhD

CONTACT

backs@musc.edu

Principal Investigator

Sudie Back, PhD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29401

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Sudie Back, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-29

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2021-03-29

Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

PTSD
Alcohol Use Disorder