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NCT03046836 · ClinicalTrials.gov registry record · Phase 2
Oxytocin, Alcohol Craving, and Intimate Partner Aggression
A Phase 2 study of Alcohol Use, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT03046836: Completed Phase 2 study of Alcohol Use, sponsored by Medical University of South Carolina.
NCT03046836 is a Phase 2 study of Alcohol Use that has completed, run by Medical University of South Carolina. The registered enrollment target is 200 participants, below the 262-participant average among 23 other Alcohol Use trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03046836, a Phase 2 study of Alcohol Use, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is scant. The proposed study is designed to address these gaps in the literature by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and aggression among couples with AUD and co-occurring IPA.
Primary Outcome
Change in subjective alcohol craving as measured by a Visual Analogue Scale (VAS) between time point 3 (before the alcohol cue) and 4 (after the alcohol cue). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxytocin
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2021-04-11 |
| Phase | Phase 2 |
What the finished NCT03046836 record still lists
NCT03046836 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 262-participant average among 23 other Alcohol Use trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Alcohol Use appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03046836 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT03046836 about?
NCT03046836 is a clinical study titled "Oxytocin, Alcohol Craving, and Intimate Partner Aggression". Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. Howev...
What is the current status of trial NCT03046836?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2017-07-01. Estimated completion is 2021-04-11.
What conditions does trial NCT03046836 study?
This clinical trial studies the following conditions: Alcohol Use.
What interventions are being tested in trial NCT03046836?
The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT03046836?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03046836 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
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Where NCT03046836's enrollment target sits among peer trials
200 8th of 23 higher than 16 of 23 other Alcohol Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use 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.
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