Oxytocin to Enhance Integrated Treatment for AUD and PTSD (NCT04523922) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Oxytocin to Enhance Integrated Treatment for AUD and PTSD
United States175 participantsStarted 2021-03-29
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in alcohol use
Timeframe: From baseline to week 12 and 3 and 6 month follow ups
2
Change in PTSD symptom severity - clinician rated
Timeframe: From baseline to week 12 and 3 and 6 month follow ups
3
Change in PTSD symptom severity - self report
Timeframe: From baseline to week 12 and 3 and 6 month follow ups
. 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.