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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: Recruiting Phase 4 study of Alcohol Use Disorder, sponsored by Milky Kohno.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Drinking days and average number of weekly standard drinks will be measured at baseline and at follow-up
Conditions Studied
Interventions
- DRUG Naltrexone
Study Locations (1)
Oregon
- VA Portland Health Care System - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-05-02 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 4 |
What NCT06426303 shows while recruiting
NCT06426303 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (70% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06426303's enrollment target sits among peer trials
100 81st of 184 higher than 99 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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