Intranasal Insulin for Treatment of Alcohol Use Disorder

NCT ID: NCT05988632

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2027-01-31

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.

Detailed Description

Aims in this RCT testing the effect of IN insulin, compared to placebo, in individuals with AUD include the following:

AIM 1: to assess the safety, tolerability and acceptability of IN insulin as a pharmacological intervention for AUD. The data collected in this aim will monitor possible adverse events and yield qualitative and quantitative data to finalize the feasibility and acceptability of IN insulin as an AUD pharmacotherapy.

Aim 2 (alcohol-drug interaction): to assess the safety and tolerability of IN insulin when administered with alcohol. The investigators will use a battery of physiological/psychological assessments that measures potential adverse events, alcohol subjective response and alcohol pharmacokinetics endpoints.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Regular Human Insulin then Placebo

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Placebo then Regular Human Insulin

Intervention Type: DRUG

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

Interventions

Regular Human Insulin then Placebo

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

Intervention Type: DRUG

Placebo then Regular Human Insulin

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

Intervention Type: DRUG

Other Intervention Names

Novolin R; Novolin R

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Carolina L Haass-Koffler

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brown University

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carolina L Haass-Koffler

Role: CONTACT

carolina_haass-koffler@brown.edu

4155191385

Facility Contacts

Zoe Brown

Role: primary

alcohol-stress-study@brown.edu

(401) 863-6646

Brian Gully

Role: backup

alcohol-stress-study@brown.edu

(401) 863-6646

References

Haass-Koffler CL, Kashyap B, Gully BJ, Nambiar SS, Hornbacher R, Foster SL, Silberman Y, Swift RM, Hanson LR, Frey WH 2nd. Intranasal insulin for the treatment of alcohol use disorder: design and methodology of an alcohol interaction randomized controlled trial. Contemp Clin Trials Commun. 2025 Jun 10;46:101509. doi: 10.1016/j.conctc.2025.101509. eCollection 2025 Aug.

Reference Type: DERIVED

PMID: 40584152 (View on PubMed)

Other Identifiers

STUDY00000134

Identifier Type: -

Identifier Source: org_study_id