Exploring how sex differences affect treatment response in alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to identify sex-specific biomarkers that influence susceptibility to Alcohol Use Disorder (AUD) and how treatment responses differ between sexes. It involves a twelve-week randomized placebo-controlled trial of naltrexone (NTX) in 100 participants with AUD, including 50 women, alongside 50 healthy controls. Participants will undergo comprehensive assessments, including behavioral, neuropsychological, and neuroimaging measures, to evaluate the effects of trauma, emotion regulation, and inflammation on limbic function. The study seeks to understand the mechanisms by which NTX may reduce alcohol use through these interactions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Clinically significant neurological, endocrine, hepatic, or systemic disease that would compromise safe participation or confound outcomes
* Left-handedness
* Axis-1 psychiatric diagnoses other than anxiety, depression or post-traumatic stress disorder
* Recreational or prescriptive use of psychotropic medications
* Recreational or prescriptive use of opioid medications or have a past or current history of abuse or dependence on opioids
* MRI contraindications (e.g. metal in body)
* Positive urine drug screen, except for nicotine and marijuana, on test days
* Women who are pregnant or breastfeeding
* Participants on hormonal therapy or treatments other than pregnancy contraceptives
* Autoimmune or neurodegenerative diseases that present with neuroinflammation (multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, Parkinson's)
* Current participation in an investigational drug study
* Alcohol group: \< 5 days and \> 3 weeks of abstinence from alcohol
* 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.
* Non-english speaker

Where it's running

• VA Portland Health Care System
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Jazryn Nagum
• Email: vhaporhoffmanlab@va.gov
• Phone: 503-721-7964

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.