Intranasal Insulin for Treatment of Alcohol Use Disorder (ITA)
Alcohol Use Disorder
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Insulin, Then Placebo
Placebo, Then Insulin
There will be one single administration of intranasal human insulin (80IU) before alcohol self-administration. After a one week washout period, there will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration.
There will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration. After a one week washout period, there will be one single administration of intranasal human insulin (80IU) before alcohol self-administration.