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Intranasal Insulin for Treatment of Alcohol Use Disorder

RecruitingPhase 1/2

Who can join

Ages 21 and older · All sexes

Full 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)

About the study

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.

What is being tested

Sponsor: Brown University · Participants: 40 · Started: Feb 25, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT05988632

Locations in the U.S.

Rhode IslandBrown University, Providence

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.