Intranasal Insulin for Treatment of Alcohol Use Disorder

NCT05988632 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY00000134
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• intranasal adverse events

  Adverse event reported during the drug administration

  From baseline to post-treatment (1 day)

Secondary Outcomes (1)

• insulin alcohol interaction

  From baseline to post-treatment (1 day)

Study Arms (2)

Insulin, Then Placebo

EXPERIMENTAL

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.

Drug: Regular Human Insulin then Placebo

Placebo, Then Insulin

EXPERIMENTAL

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.

Drug: Placebo then Regular Human Insulin

Interventions

Regular Human Insulin then Placebo DRUG

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

Also known as: Novolin R

Insulin, Then Placebo

Placebo then Regular Human Insulin DRUG

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

Also known as: Novolin R

Placebo, Then Insulin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40584152 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Insulin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Carolina L Haass-Koffler

CONTACT

4155191385; carolina_haass-koffler@brown.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)