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RECRUITING
NCT05988632
PHASE1/PHASE2

Intranasal Insulin for Treatment of Alcohol Use Disorder

Sponsor: Brown University

View on ClinicalTrials.gov

Summary

This is a randomized controlled trial (RCT), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting, randomized participants will receive a single dose of IN insulin (80IU) or an IN matched placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (BrAC) to 0.08g/dL.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-25

Completion Date

2027-01-31

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

DRUG

Regular Human Insulin then Placebo

Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)

DRUG

Placebo then Regular Human Insulin

Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)

Locations (1)

Brown University

Providence, Rhode Island, United States