RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Intranasal Insulin for Treatment of Alcohol Use Disorder

Sponsor: Brown University • ClinicalTrials.gov ID: NCT05988632

Registry updated: 2026-09-30

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Description

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.

Interventions

Regular Human Insulin then Placebo (Drug)
Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)
Placebo then Regular Human Insulin (Drug)
Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)

Eligibility 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)

Conditions

Alcohol Use Disorder

Locations

Brown University — Providence, Rhode Island, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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