Alcohol Use Disorder
Conditions
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) 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.
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 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 physiological/psychological assessments that measures potential adverse events, alcohol subjective response and alcohol pharmacokinetics endpoints.
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)
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intranasal adverse events | From baseline to post-treatment (1 day) | Adverse event reported during the drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insulin alcohol interaction | From baseline to post-treatment (1 day) | Adverse event reported during the alcohol administration |
Countries
United States
Contacts
Primary ContactCarolina L Haass-Koffler
Outcome results
None listed