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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 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.

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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.

Interventions

  • DRUG Instranasal Oxytocin

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2022-06-29
Est. Completion 2023-10-13
Phase Phase 2

What the Registry Record Tells You About NCT03878316

The ClinicalTrials.gov registry entry for NCT03878316 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Instranasal Oxytocin is the first listed.

NCT03878316 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.