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NCT03878316 · ClinicalTrials.gov registry record · Phase 2
Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03878316: Completed Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT03878316 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878316, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
Primary: The primary objective of the study is to compare the efficacy of intranasal oxytocin in reducing the weekly percentage of heavy drinking days over the 10 weeks of maintenance treatment among subjects with moderate to severe Alcohol Use Disorder (AUD). A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Secondary: Secondary objectives include assessment of other measures of the effects of oxytocin compared with placebo on reduction of alcohol use as well as effects on psychological assessments, alcohol craving, alcohol-related consequences, cigarette smoking and other nicotine use, retention in the study, safety, and application site (nares) tolerability throughout the study.
Primary Outcome
The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method.
Interventions
- DRUG Instranasal Oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2023-10-13 |
| Phase | Phase 2 |
What the finished NCT03878316 record still lists
NCT03878316 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Instranasal Oxytocin is the first listed.
NCT03878316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03878316 about?
NCT03878316 is a clinical study titled "Intranasal Oxytocin for the Treatment of Alcohol Use Disorder". Primary: The primary objective of the study is to compare the efficacy of intranasal oxytocin in reducing the weekly percentage of heavy drinking days over the 10 weeks of maintenance treatment among subjects with moderate to severe Alcohol Use Disorder (AUD). A "heavy drinking day" is 4 or more dri...
What is the current status of trial NCT03878316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2022-06-29. Estimated completion is 2023-10-13.
What interventions are being tested in trial NCT03878316?
The interventions under investigation include: Instranasal Oxytocin (DRUG).
Who is sponsoring clinical trial NCT03878316?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03878316's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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