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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Milky Kohno
Study ID
NCT06426303
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Naltrexone — DRUG
    12-week randomized double blinded placebo-controlled drug trial titrating drug/placebo dose after 1 week.

Study Details

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.

Key Dates

Start date
May 2, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Alcohol Use Disorder (AUD)
    Drug: Naltrexone Half of the study participants with AUD will take an oral tablet of 50 mg naltrexone once daily for one week followed by 11 weeks of 100 mg naltrexone orally, once daily. Drug: Placebo oral tablet The other half of study participants will receive an identical looking placebo in tablet form and take the medication using an identical schedule as the real drug. Drug type will be randomized.
  • No Intervention: Healthy Controls
    Baseline measures will be taken but controls will not continue to the drug trial.

Primary Outcome Measure

Change from baseline in alcohol use (number of drinking days, amount used per day) [ Time Frame: Baseline and Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Portland Health Care SystemPortlandOregon97239
Jazryn Nagum
[email protected]
503-721-7964

Find similar trials in Portland, OR

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
VA Portland Health Care System· Portland, OR

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