Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder
Key facts
- Who runs it
- Milky Kohno
- Where
- Portland, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 100 people, planned
- Started
- 2 May 2024
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Naltrexone
- Record updated
- 6 October 2026
Who can take part
- Age
- 18 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 18-60 years old
- Veteran enrolled in VHA healthcare; Alcohol Group:
- must meet diagnosis for recent alcohol-use disorder (DSM-V)
- willing to return for follow-up visits and can participate for 12-weeks; Control Group:
- must not meet DSM-V criteria for a use disorder other than nicotine
Who cannot take part
- Recreational or prescriptive use of psychotropic medications
- Positive urine drug screen, except for nicotine and marijuana, on test days
- Participants on hormonal therapy or treatments other than pregnancy contraceptives
- Current participation in an investigational drug study
- Clinically significant neurological, endocrine, hepatic, or systemic disease that would compromise safe participation or confound outcomes
- Axis-1 psychiatric diagnoses other than anxiety, depression or post-traumatic stress disorder
- Recreational or prescriptive use of opioid medications or have a past or current history of abuse or dependence on opioids
- Autoimmune or neurodegenerative diseases that present with neuroinflammation (multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, Parkinson's)
- Alcohol group: Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit of normal, gastrointestinal or renal disease that would significantly impair absorption, metabolism or excretion of study drug, or require medical treatment
- Left-handedness
- MRI contraindications (e.g. metal in body)
- Women who are pregnant or breastfeeding
- Alcohol group: < 5 days and > 3 weeks of abstinence from alcohol
- Non-english speaker
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Where in United States
- VA Portland Health Care SystemPortland, United StatesContact: Jazryn NagumTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Alcohol Use Disorder (AUD)Treatment being tested
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.
Treatment: Naltrexone
- Healthy ControlsNo study treatment, for comparison
Baseline measures will be taken but controls will not continue to the drug trial.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06426303, who can take part
- Record updated
- 6 October 2026