Intranasal Insulin for Treatment of Alcohol Use Disorder

• Status: Recruiting
• Trial end date: 2025-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• ≥21 years

• meet any DSM-5 criteria score for AUD

• Individuals who, in the last month, have consumed at least the same amount of alcohol that will be administered in the laboratory procedure (i.e. to reach BrAC levels of 0.08g/dl, ~two drinks in one occasion)

• BrAC=0.00g/dL at each visit

• good health as confirmed by medical history, physical examination and lab tests

• willing to adhere to the study procedures

• understand informed consent and questionnaires in English at an 8th grade level

• willing to have glucose monitored by finger stick during the laboratory procedures

Exclusion Criteria:

• • female identifying who are breastfeeding or pregnant (assessed by a urine screen)

• individuals with diabetes

• history of suicide attempts in the last three years

• current diagnosis of other substance use disorder (other than nicotine or cannabis)

• use of drugs (e.g. stimulants/opioids) at each alcohol administration session (by urine tox screen)

• cannabis intoxication (by clinical assessments)

• use of medications that may interact with insulin and alcohol (by Micromedex database)

• hypersensitivity to insulin

• any nasal disease/congestion that may interfere with intranasal drug absorption;

• baseline hypoglycemia (blood glucose ≤65mg/dL) or hyperglycemia (blood glucose >200mg/dL) (by finger stick)