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Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of 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 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California
Los Angeles, California, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Virginia
Charlottesville, Virginia, United States
Start Date
June 29, 2022
Primary Completion Date
October 13, 2023
Completion Date
October 13, 2023
Last Updated
August 7, 2025
100
ACTUAL participants
Instranasal Oxytocin
DRUG
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT05855668
NCT07071779
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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