NCT05988632 (ITA) is a Phase 1, PHASE2 clinical trial of Regular Human Insulin then Placebo in Alcohol Use Disorder, sponsored by Brown University.

Who is sponsoring NCT05988632?

NCT05988632 is sponsored by Brown University.

What drugs are being tested in NCT05988632?

Interventions in NCT05988632: Regular Human Insulin then Placebo, Placebo then Regular Human Insulin.

What condition does NCT05988632 study?

NCT05988632 studies Alcohol Use Disorder.

Is NCT05988632 still recruiting?

NCT05988632 is currently recruiting now. Last updated 5 September 2025.

Last reviewed 2025-09-05 · How we verify

NCT05988632: ITA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intranasal Insulin for Treatment of Alcohol Use Disorder

Recruiting now Phase 1, PHASE2 Last updated 5 September 2025

What this trial tests

Phase 1, PHASE2 trial testing Regular Human Insulin then Placebo in Alcohol Use Disorder in 40 participants. Currently enrolling.

Timeline

25 February 2025

Primary endpoint
31 December 2026

31 January 2027

Quick facts

Lead sponsor	Brown University
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	25 February 2025
Primary completion	31 December 2026
Estimated completion	31 January 2027
Sites	1 location across United States

Drugs / interventions tested

Regular Human Insulin then Placebo — full drug profile →
Placebo then Regular Human Insulin — full drug profile →

Conditions studied

Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Brown University

Who can join

21 and older, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Intranasal insulin for the treatment of alcohol use disorder: design and methodology of an alcohol interaction randomized controlled trial.
Haass-Koffler CL, Kashyap B, Gully BJ, Nambiar SS, et al · · 2025 · cited 1× · PMID 40584152 · DOI 10.1016/j.conctc.2025.101509
High-dose intranasal insulin in an adaptive dose-escalation study in healthy human participants.
Schmitzberger F, Fowler J, Hsu CH, Pai MP, et al · · 2024 · cited 1× · PMID 39558506 · DOI 10.1111/cts.70071

Verify or expand the search:

Other recruiting trials for Alcohol Use Disorder

Currently open trials in the same condition.

NCT06860607 — Environment and Alcohol: A Pilot Study · Phase 1 · recruiting
NCT07325266 — Human Laboratory Study of Apremilast for Alcohol Use Disorder · Phase 2 · recruiting
NCT07046819 — Tirzepatide in MetALD · Phase 2 · recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
NCT07056894 — Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis · NA · recruiting

Other Brown University trials

Trials by the same sponsor.

NCT07502872 — TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-g · Phase 2 · not yet recruiting
NCT07118618 — Probenecid Administration for Alcohol Craving and Consumption · Phase 2 · recruiting
NCT07398443 — Using Novel Behavioral Economic Measures to Characterize Dual Marijuana and Tobacco Use in Young Adults · NA · recruiting
NCT05901766 — Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment · Phase 4 · not yet recruiting
NCT06974604 — Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05988632 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Brown University
Last refreshed: 5 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05988632.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing