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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: Completed Phase 2 study of Alcohol Use Disorder and Couples, sponsored by Medical University of South Carolina.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent days abstinent (days with no alcohol consumption) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of drinking days representing better outcomes. Time Line Follow Back (TLFB), a clinician assessed measure, will be used t
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 |
What the finished NCT03846505 record still lists
NCT03846505 is an interventional study that assigns participants to a tested intervention. The registered 192 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 (41% lower).
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 a single indexed study location in 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.
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 NCT03846505's enrollment target sits among peer trials
192 49th of 184 higher than 136 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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