Oxytocin to Enhance Integrated Treatment for AUD and PTSD
COPE+OT
1 other identifier
interventional
175
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedStudy Start
First participant enrolled
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 9, 2026
April 1, 2026
5.2 years
August 19, 2020
April 3, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Change in alcohol use
Change in percent days abstinent and heavy drinking days as measured by the TimeLine Follow-Back (TLFB).
From baseline to week 12 and 3 and 6 month follow ups
Change in PTSD symptom severity - clinician rated
Change in clinician-rated PTSD symptom severity will be measured with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
From baseline to week 12 and 3 and 6 month follow ups
Change in PTSD symptom severity - self report
Change in self-reported PTSD symptom severity will be measured with the PTSD Checklist for DSM-5 (PCL-5).
From baseline to week 12 and 3 and 6 month follow ups
Study Arms (2)
Oxytocin Treatment Group
EXPERIMENTALParticipants 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.
Placebo Group
ACTIVE COMPARATORParticipants 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.
Interventions
40 IU Intranasal Oxytocin self administered 30 minutes prior to each COPE session.
Placebo (intranasal saline spray) self administered 30 minutes prior to each COPE session.
12 weekly sessions of COPE therapy for PTSD and AUD.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29401, United States
Related Publications (1)
Back SE, Flanagan JC, Killeen T, Saraiya TC, Brown DG, Jarnecke AM, Rothbaum AO, Joseph J, Ana ES, de Arellano A, Shoemaker HL, Dixon RA, Nietert PJ, Brady KT. COPE and oxytocin for the treatment of co-occurring PTSD and alcohol use disorder: Design and methodology of a randomized controlled trial in U.S. military veterans. Contemp Clin Trials. 2023 Mar;126:107084. doi: 10.1016/j.cct.2023.107084. Epub 2023 Jan 13.
PMID: 36646315DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sudie Back, PhD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 24, 2020
Study Start
March 29, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 9, 2026
Record last verified: 2026-04