Actively Recruiting
Intranasal Insulin for Treatment of Alcohol Use Disorder
Led by Brown University · Updated on 2025-09-05
40
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intranasal Insulin for Treatment of Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older
- Meet any DSM-5 criteria for Alcohol Use Disorder
- Consumed at least the amount of alcohol to reach BrAC 0.08 g/dL (about two drinks) in the past month
- Breath alcohol content of 0.00 g/dL at each visit
- Good health confirmed by medical history, physical exam, and lab tests
- Willing to follow study procedures
- Able to understand informed consent and questionnaires in English at an 8th grade level
- Willing to have blood glucose monitored by finger stick during procedures
You will not qualify if you...
- Female individuals who are pregnant or breastfeeding
- Diagnosis of diabetes
- History of suicide attempts within the last three years
- Current diagnosis of other substance use disorders (except nicotine or cannabis)
- Use of drugs such as stimulants or opioids during alcohol administration sessions
- Cannabis intoxication at assessment
- Use of medications that interact with insulin and alcohol
- Hypersensitivity to insulin
- Nasal disease or congestion affecting intranasal drug absorption
- Baseline blood glucose less than or equal to 65 mg/dL or greater than 200 mg/dL
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brown University
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
C
Carolina L Haass-Koffler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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