Recruiting
Phase 1
Phase 2

Intranasal Insulin

Sponsor:

Brown University

Code:

NCT05988632

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Regular Human Insulin then Placebo

Placebo then Regular Human Insulin

Study Details

Brief 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.

Conditions

Alcohol Use Disorder

Study ID

NCT05988632

Start date

Feb 25, 2025

Status verified date

Aug, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Insulin, Then Placebo

There will be one single administration of intranasal human insulin (80IU) before alcohol self-administration. After a one week washout period, there will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration.

experimental: Placebo, Then Insulin

There will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration. After a one week washout period, there will be one single administration of intranasal human insulin (80IU) before alcohol self-administration.

Interventions

Regular Human Insulin then Placebo

Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)

Placebo then Regular Human Insulin

Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)

Primary outcome measure

  • intranasal adverse events [ Time Frame: From baseline to post-treatment (1 day) ]

Central Contacts and Locations

Central contacts

Carolina L Haass-Koffler

4155191385carolina_haass-koffler@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Zoe Brown

(401) 863-6646alcohol-stress-study@brown.edu

Brian Gully

(401) 863-6646alcohol-stress-study@brown.edu

More Information

Sponsor

Brown University

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2025-09-05.