NCT03878316

Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder
• Alcohol Misuse

Interventions

Type	Name	Description
DRUG	Instranasal Oxytocin	Intranasal Oxytocin - concentrated formulation - 35 IU per dose

Timeline

• Start date: 2022-06-29
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2019-03-18
• Last updated: 2025-08-07
• Results posted: 2025-07-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study