Actively Recruiting

Phase 4
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06426303

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

Led by Milky Kohno · Updated on 2024-07-18

100

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

Sponsors

M

Milky Kohno

Lead Sponsor

P

Portland VA Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Veteran enrolled in VHA healthcare
  • Alcohol group: diagnosed with recent alcohol use disorder (DSM-V criteria)
  • Alcohol group: willing and able to participate in 12-week follow-up visits
  • Control group: no diagnosis of substance use disorder other than nicotine
Not Eligible

You will not qualify if you...

  • Significant neurological, endocrine, liver, or systemic disease impacting safety or study outcomes
  • Left-handedness
  • Axis-1 psychiatric disorders other than anxiety, depression, or PTSD
  • Use of psychotropic medications recreationally or by prescription
  • Use or history of opioid medication use or abuse
  • MRI contraindications such as metal in the body
  • Positive urine drug screen on test days except for nicotine and marijuana
  • Women who are pregnant or breastfeeding
  • Use of hormonal therapy or treatments other than pregnancy contraceptives
  • Autoimmune or neurodegenerative diseases causing neuroinflammation
  • Current participation in another investigational drug study
  • Alcohol group: less than 5 days or more than 3 weeks of alcohol abstinence
  • Alcohol group: liver disease requiring treatment or elevated liver enzymes above three times normal limits, or significant gastrointestinal or kidney disease
  • Non-English speakers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Portland Health Care System

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

J

Jazryn Nagum

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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