Status:
RECRUITING
Intranasal Insulin for Treatment of Alcohol Use Disorder
Lead Sponsor:
Brown University
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
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) randomi...
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 p...
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)
Key Trial Info
Start Date :
February 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05988632
Start Date
February 25 2025
End Date
January 31 2027
Last Update
September 5 2025
Active Locations (1)
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1
Brown University
Providence, Rhode Island, United States, 02903