Clinical Trial

Intranasal Insulin for Treatment of Alcohol Use Disorder

Study acronym: ITA
Recruiting Phase 1/2
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-08-09; most recent amendment 2025-08-28.
Status change: Not Yet Recruiting → Recruiting 2024-03-25
Trial Details
NCT Number NCT05988632
Lead Sponsor Brown University
Conditions Alcohol Use Disorder
Enrollment 40 participants
Start Date 2025-02-25
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-05