Intranasal Insulin for Treatment of Alcohol Use Disorder

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT05988632

Run by

Brown University

People needed

40

Starts

2025-02-25

Expected to finish

2027-01-31

Last updated by the study team

2025-09-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• • 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)

Where it is running

• Brown University — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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