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Hormone Therapy

Regular Human Insulin then Placebo for Alcoholism (ITA Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to post-treatment (1 day)

Awards & highlights

ITA Trial Summary

This trial will test the effects of insulin on individuals with Alcohol Use Disorder. Participants will be randomly assigned to receive either insulin or a placebo through the nose. They will then undergo tests in a bar-like

Who is the study for?

This trial is for adults over 21 with Alcohol Use Disorder who regularly consume alcohol and are in good health. Participants must understand English at an 8th grade level, agree to glucose monitoring by finger stick, and meet DSM-5 criteria for AUD. They cannot participate if they don't adhere to study procedures.Check my eligibility

What is being tested?

The trial tests the effects of intranasal insulin versus a saline placebo on individuals with Alcohol Use Disorder in a controlled bar setting. Each participant will try both treatments at different times (crossover design) without knowing which one they're getting (double-blind).See study design

What are the potential side effects?

Potential side effects may include reactions related to insulin administration such as low blood sugar levels or nasal discomfort from the delivery method. Side effects specific to this form of treatment have not been detailed.

ITA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to post-treatment (1 day)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to post-treatment (1 day)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to post-treatment (1 day) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

intranasal adverse events

Secondary outcome measures

insulin alcohol interaction

ITA Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, Then InsulinExperimental Treatment1 Intervention

There will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration. After a one week washout period, there will be one single administration of intranasal human insulin (80IU) before alcohol self-administration.

Group II: Insulin, Then PlaceboExperimental Treatment1 Intervention

There will be one single administration of intranasal human insulin (80IU) before alcohol self-administration. After a one week washout period, there will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Brown UniversityLead Sponsor

456 Previous Clinical Trials

558,276 Total Patients Enrolled

29 Trials studying Alcoholism

5,475 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity for patient enrollment in this clinical trial?

"Indeed, the data on clinicaltrials.gov confirms that this particular research study is actively seeking participants. The trial was initially listed on March 25th, 2024 and its most recent update was also made on the same date. A total of 40 patients are sought after at a single designated site for enrollment in this study."

Answered by AI

Are patients currently eligible to enroll in this research study?

"Indeed, the details on clinicaltrials.gov highlight that this particular medical investigation is actively seeking suitable candidates. The trial was first listed on March 25th, 2024 and last revised on the same day. Approximately 40 participants are being sought from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intranasal Insulin for Treatment of Alcohol Use Disorder

Carolina Haass-Koffler 2024. "Intranasal Insulin for Treatment of Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05988632.