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NCT04523922 · ClinicalTrials.gov registry record · Phase 2
Oxytocin to Enhance Integrated Treatment for AUD and PTSD
A Phase 2 study of Alcohol Use Disorder and PTSD, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT04523922: Recruiting Phase 2 study of Alcohol Use Disorder and PTSD, sponsored by Medical University of South Carolina.
NCT04523922 is a Phase 2 study of Alcohol Use Disorder and PTSD that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 180 participants, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04523922, a Phase 2 study of Alcohol Use Disorder and PTSD, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change in percent days abstinent and heavy drinking days as measured by the TimeLine Follow-Back (TLFB).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 40 IU Intranasal Oxytocin
- BEHAVIORAL Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What NCT04523922 shows while recruiting
NCT04523922 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (45% lower).
The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04523922 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT04523922 about?
NCT04523922 is a clinical study titled "Oxytocin to Enhance Integrated Treatment for AUD and PTSD". 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 ...
What is the current status of trial NCT04523922?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2021-03-29. Estimated completion is 2026-12-01.
What conditions does trial NCT04523922 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, PTSD.
What interventions are being tested in trial NCT04523922?
The interventions under investigation include: Placebo (DRUG), 40 IU Intranasal Oxytocin (DRUG), Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (BEHAVIORAL).
Who is sponsoring clinical trial NCT04523922?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04523922 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04523922's enrollment target sits among peer trials
180 51st of 184 higher than 132 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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