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NCT03846505 · ClinicalTrials.gov registry record · Phase 2
Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
A Phase 2 study of Alcohol Use Disorder and Couples, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
- 1
- Study location
NCT03846505 is a Phase 2 study of Alcohol Use Disorder and Couples that has completed, run by Medical University of South Carolina. The registered enrollment target is 192 participants, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03846505, a Phase 2 study of Alcohol Use Disorder and Couples, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
- 1
- Study location
Study Summary
Alcohol Behavioral Couples Therapy (ABCT) is a manualized 12-session, weekly psychosocial intervention that simultaneously reduces alcohol use disorder (AUD) severity and improves relationship functioning. However, there remains room to improve ABCT outcomes. A growing literature suggests that intranasal oxytocin is a medication that holds promise to achieve that goal. Oxytocin has demonstrated the ability to increase prosocial behavior (e.g., trust, safety, social cognition) and restore sensitivity to natural rewards such as interpersonal relationships that are commonly eroded in the context of addiction. Oxytocin has also demonstrated the ability to reduce substance use behaviors (e.g., craving, self-administration, tolerance, withdrawal), and improves the neurobiological foundations of AUD. The primary objective of this Stage II study is to test the efficacy of oxytocin versus placebo in improving (1) AUD symptom severity, (2) relationship functioning, and (3) corticolimbic connectivity among couples receiving ABCT therapy.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Oxytocin
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03846505
The ClinicalTrials.gov registry entry for NCT03846505 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (41% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03846505 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT03846505 about?
NCT03846505 is a clinical study titled "Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)". Alcohol Behavioral Couples Therapy (ABCT) is a manualized 12-session, weekly psychosocial intervention that simultaneously reduces alcohol use disorder (AUD) severity and improves relationship functioning. However, there remains room to improve ABCT outcomes. A growing literature suggests that intra...
What is the current status of trial NCT03846505?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2019-05-16. Estimated completion is 2024-01-31.
What conditions does trial NCT03846505 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, Couples.
What interventions are being tested in trial NCT03846505?
The interventions under investigation include: Placebo (OTHER), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT03846505?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03846505 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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