NCT05988632 Intranasal Insulin for Treatment of Alcohol Use Disorder
| NCT ID | NCT05988632 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Brown University |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-02-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized controlled trial (RCT), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting, randomized participants will receive a single dose of IN insulin (80IU) or an IN matched placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (BrAC) to 0.08g/dL.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05988632 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05988632 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05988632 currently recruiting?
Yes, NCT05988632 is actively recruiting participants. Contact the research team at carolina_haass-koffler@brown.edu for enrollment information.
Where is the NCT05988632 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT05988632 clinical trial?
NCT05988632 is sponsored by Brown University. The trial plans to enroll 40 participants.