Alcohol Use Disorder Clinical Trial
— ITAOfficial title:
Intranasal Insulin for Treatment of Alcohol Use Disorder
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 30, 2025 |
Est. primary completion date | March 25, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Brown University | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Brown University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intranasal adverse events | Adverse event reported during the drug administration | From baseline to post-treatment (1 day) | |
Secondary | insulin alcohol interaction | Adverse event reported during the alcohol administration | From baseline to post-treatment (1 day) |
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