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RECRUITING Phase 1

Intranasal Insulin for Treatment of Alcohol Use Disorder

NCT05988632 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Regular Human Insulin then Placebo
  • DRUG Placebo then Regular Human Insulin

Study Locations (1)

Rhode Island

  • Brown University — Providence

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-02-25
Est. Completion 2027-01-31
Phase Phase 1

Sponsor

Brown University

268 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05988632

The ClinicalTrials.gov registry entry for NCT05988632 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 268 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions — of which Regular Human Insulin then Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05988632 reports 1 study location spanning 1 distinct geographic area — top geographies include Rhode Island. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05988632 about?

NCT05988632 is a clinical study titled "Intranasal Insulin for Treatment of Alcohol Use Disorder". 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 si...

What is the current status of trial NCT05988632?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-02-25. Estimated completion is 2027-01-31.

What conditions does trial NCT05988632 study?

This clinical trial studies the following conditions: Alcohol Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05988632?

The interventions under investigation include: Regular Human Insulin then Placebo (DRUG), Placebo then Regular Human Insulin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05988632?

This trial is sponsored by Brown University, which has 268 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05988632 being conducted?

This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial