Using intranasal insulin to treat alcohol use disorder
Intranasal Insulin for Treatment of Alcohol Use Disorder
This study is testing if using intranasal insulin can help people with alcohol use disorder by seeing how it affects them when they drink alcohol.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Brown University Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05988632 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled, crossover, double-blind, placebo-controlled study involving non-treatment-seeking individuals with Alcohol Use Disorder (AUD). Participants will receive either intranasal insulin or a placebo in a controlled laboratory setting, followed by an alcohol challenge to assess the effects. The study aims to evaluate the safety, tolerability, and acceptability of intranasal insulin as a potential pharmacological intervention for AUD, as well as its interaction with alcohol. A total of 40 participants will be monitored for adverse events and physiological responses during the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 and older who meet DSM-5 criteria for alcohol use disorder and have a recent history of alcohol consumption.
Not a fit: Patients who are pregnant, breastfeeding, or have diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel pharmacological treatment option for individuals struggling with alcohol use disorder.
How similar studies have performed: While the approach of using intranasal insulin for AUD is novel, similar studies exploring pharmacological interventions for substance use disorders have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Providence, Rhode Island
- Brown University — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Carolina L Haass-Koffler
- Email: carolina_haass-koffler@brown.edu
- Phone: 4155191385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.