Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
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 12 weeks of 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, and safety and tolerability throughout the
study.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)