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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03878316
Study type Interventional
Source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Contact Megan Ryan, MBA
Phone 3014434225
Email mryan1@nih.gov
Status Recruiting
Phase Phase 2
Start date May 5, 2022
Completion date March 2024

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