Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

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.

Timeline

Start

2022-06-29

Primary completion

2023-10-13

Completion

2023-10-13

Publications

• Tiouririne NA, Legan JA, Devine E, Lee K, Weerts EM, Ellis JD, Ray L, Shoptaw S, Falk D, Ryan M, Litten R, Seneviratne C, Ransom J, Scott C. Intranasal Oxytocin for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled Multisite Trial Assessing Efficacy and Safety. Alcohol Clin Exp Res (Hoboken). 2026 Jul;50(7):e70326. doi: 10.1111/acer.70326.

Drugs

Indications