Intranasal Insulin for Treatment of Alcohol Use Disorder

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.

Conditions

Alcohol Use Disorder

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Study Overview

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Study Details

Study overview

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.

Intranasal Insulin for Treatment of Alcohol Use Disorder

Intranasal Insulin for Treatment of Alcohol Use Disorder

Condition
Alcohol Use Disorder
Intervention / Treatment

-

Contacts and Locations

Providence

Brown University, Providence, Rhode Island, United States, 02903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * • 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)

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brown University,

Study Record Dates

2025-03-30