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NCT05988632
Intranasal Insulin for Treatment of Alcohol Use Disorder
Conditions: Alcohol Use Disorder
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 40
Sponsor: Brown University
Location: Brown University Providence Rhode Island
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.
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)
Source: ClinicalTrials.gov (NCT05988632). StuddyBuddy aggregates publicly available trial information.