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Intranasal Insulin for Alcohol Use Disorder

This study is looking into whether intranasal insulin (insulin given through the nose) can help people with Alcohol Use Disorder (AUD). Researchers want to see if intranasal insulin is safe and well-tolerated, and how it interacts with alcohol. You would receive either intranasal insulin or a placebo (a saline solution that looks like the study drug) through your nose. The study will measure any side effects you might experience. To join, you must be at least 21 years old and meet specific criteria for AUD. The study aims to enroll 40 participants.

Study design
This is a randomized, double-blind, placebo-controlled study with 40 participants. You would receive both intranasal insulin and a placebo at different times.
What's involved
You would participate in a bar laboratory setting, receive a single dose of intranasal insulin or placebo, and undergo a cue-reactivity task and an alcohol challenge.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored from baseline to one day after treatment.

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NCT05988632

Intranasal Insulin for Treatment of Alcohol Use Disorder

Recruiting
PHASE1Ages 21+InterventionalTreatment
Brown University
~40 participants
Updated 2025-09-05 on ClinicalTrials.gov
What's tested:Regular Human Insulin then PlaceboPlacebo then Regular Human Insulin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
intranasal adverse events
Measured over From baseline to post-treatment (1 day)

Conditions

Alcohol Use Disorder

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
Rhode Island1

Who to contact

Carolina L Haass-Koffler
[email protected]
4155191385
Email the study team

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Eligibility criteria

Inclusion

≥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

• 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)

What this trial measures

  • intranasal adverse eventsFrom baseline to post-treatment (1 day)

    Adverse event reported during the drug administration