Intranasal Insulin for Treatment of Alcohol Use Disorder
Brown University
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.
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 pharmacological intervention for AUD. The data collected in this aim will monitor possible adverse events and yield qualitative and quantitative data to finalize the feasibility and acceptability of IN insulin as an AUD pharmacotherapy. Aim 2 (alcohol-drug interaction): to assess the safety and tolerability of IN insulin when administered with alcohol. The investigators will use a battery of physi…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRegular Human Insulin then Placebo
Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)
- DrugPlacebo then Regular Human Insulin
Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)
Location
- Brown UniversityProvidence, Rhode Island