Intranasal Insulin for Treatment of Alcohol Use Disorder

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.

Timeline

Start

2025-02-25

Primary completion

2026-12-31

Completion

2027-01-31

Publications

• Haass-Koffler CL, Kashyap B, Gully BJ, Nambiar SS, Hornbacher R, Foster SL, Silberman Y, Swift RM, Hanson LR, Frey WH 2nd. Intranasal insulin for the treatment of alcohol use disorder: design and methodology of an alcohol interaction randomized controlled trial. Contemp Clin Trials Commun. 2025 Jun 10;46:101509. doi: 10.1016/j.conctc.2025.101509. eCollection 2025 Aug.

Drugs

Indications