Using intranasal insulin to treat alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Brown University
  Providence, Rhode Island, United States Recruiting

Study contacts

• Study coordinator: Carolina L Haass-Koffler
• Email: carolina_haass-koffler@brown.edu
• Phone: 4155191385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.