Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
VA Portland Health Care System
Portland, Oregon, United States, 97239
Actively Recruiting
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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