Intranasal Insulin for Treatment of Alcohol Use Disorder

Launched by BROWN UNIVERSITY · Aug 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of intranasal insulin, which is a medication delivered through the nose, on individuals with Alcohol Use Disorder (AUD). The aim is to see if this treatment can help reduce cravings or reactions when exposed to alcohol-related cues. The trial involves 40 participants, who will be randomly given either intranasal insulin or a placebo (a harmless substance with no active medicine) in a controlled environment, where they will also be given an alcoholic drink to evaluate how they respond.

To be eligible for this trial, participants must be at least 21 years old, have a diagnosis of AUD, and have consumed a certain amount of alcohol in the past month. Participants should be in good health and able to understand the study procedures. They will be monitored during the study, including having their blood sugar levels checked. It’s important to note that individuals who are pregnant, breastfeeding, have diabetes, or certain other health issues cannot participate. This trial is currently recruiting participants, and it could potentially offer new insights into treating AUD.

Gender

ALL

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)