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NCT06426303 · ClinicalTrials.gov registry record · Phase 4

Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder

A Phase 4 study of Alcohol Use Disorder, sponsored by Milky Kohno.

Recruiting
Registry status
Phase 4
Development phase
100
Enrollment target
1
Study location

NCT06426303 is a Phase 4 study of Alcohol Use Disorder that is actively recruiting participants, run by Milky Kohno. The registered enrollment target is 100 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06426303, a Phase 4 study of Alcohol Use Disorder, is actively recruiting participants, sponsored by Milky Kohno.

RECRUITING
Registry status
Phase 4
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical trial is to identify sex-specific biomarkers that confer greater susceptibility for Alcohol Use Disorder (AUD) and differentiate how treatment response varies by sex in people with Alcohol Use Disorder. The main questions it aims to answer are: * How does trauma affect emotion regulation, inflammation, and limbic function, and what are the sex-dependent effects of NTX (Naltrexone) on these aspects? * What is the mechanism of Naltrexone (NTX), and how does it potentially moderate reductions in alcohol use through changes in or interactions between emotion regulation, inflammation, or limbic system function? Participants will * Be consented and will undergo comprehensive screening for eligibility criteria * Complete behavioral assessments and neuropsychological assessments, as well as neurocognitive assessments and neuroimaging measures * Provide urine samples for a urine drug screen (UDS) and urine pregnancy test (for women), and have blood and a cheek swab collected and stored in the repository * Take a study drug once daily for 12 weeks and track drug usage and effects in a study journal * Undergo weekly assessment calls and bi-weekly medical follow-up safety exams Researchers will compare naltrexone to placebo in AUD to see if naltrexone is effective in reducing alcohol cravings and promoting abstinence. Researchers will also compare baseline measures between AUD and Healthy Controls.

Conditions Studied

Alcohol Use Disorder

Interventions

  • DRUG Naltrexone

Study Locations (1)

Oregon

  • VA Portland Health Care System - Portland

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-05-02
Est. Completion 2028-12-31
Phase Phase 4

Sponsor

Milky Kohno

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06426303

The ClinicalTrials.gov registry entry for NCT06426303 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (70% lower). The listed sponsor is Milky Kohno, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Naltrexone is the first listed.

NCT06426303 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

Frequently Asked Questions

What is clinical trial NCT06426303 about?

NCT06426303 is a clinical study titled "Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder". The goal of this clinical trial is to identify sex-specific biomarkers that confer greater susceptibility for Alcohol Use Disorder (AUD) and differentiate how treatment response varies by sex in people with Alcohol Use Disorder. The main questions it aims to answer are: * How does trauma affect em...

What is the current status of trial NCT06426303?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2024-05-02. Estimated completion is 2028-12-31.

What conditions does trial NCT06426303 study?

This clinical trial studies the following conditions: Alcohol Use Disorder.

What interventions are being tested in trial NCT06426303?

The interventions under investigation include: Naltrexone (DRUG).

Who is sponsoring clinical trial NCT06426303?

This trial is sponsored by Milky Kohno, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06426303 being conducted?

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

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.