Last updated: March 25, 2024
Sponsor: Brown University
Overall Status: Active - Recruiting
Phase
1/2
Condition
Alcohol Use Disorder
Addictions
Substance Abuse
Treatment
Placebo then Regular Human Insulin
Regular Human Insulin then Placebo
Clinical Study ID
NCT05988632
STUDY00000134
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofalcohol that will be administered in the laboratory procedure (i.e. to reach BrAClevels 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 laboratoryprocedures
Exclusion
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 orcannabis)
- use of drugs (e.g. stimulants/opioids) at each alcohol administration session (byurine tox screen)
- cannabis intoxication (by clinical assessments)
- use of medications that may interact with insulin and alcohol (by Micromedexdatabase)
- 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)
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo then Regular Human Insulin
Phase: 1/2
Study Start date:
March 25, 2024
Estimated Completion Date:
March 30, 2025
Study Description
Connect with a study center
Brown University
Providence, Rhode Island 02903
United StatesActive - Recruiting
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