NCT05988632

Intranasal Insulin for Treatment of Alcohol Use Disorder

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Aims in this RCT testing the effect of IN insulin, compared to placebo, in individuals with AUD include the following: AIM 1: to assess the safety, tolerability and acceptability of IN insulin as a pharmacological intervention for AUD. The data collected in this aim will monitor possible adverse events and yield qualitative and quantitative data to finalize the feasibility and acceptability of IN insulin as an AUD pharmacotherapy. Aim 2 (alcohol-drug interaction): to assess the safety and tolerability of IN insulin when administered with alcohol. The investigators will use a battery of physiological/psychological assessments that measures potential adverse events, alcohol subjective response and alcohol pharmacokinetics endpoints.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-02-25
• Primary completion: 2026-12-31
• Completion: 2027-01-31
• First posted: 2023-08-14
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study