Exploring how sex differences affect treatment response in alcohol use disorder
Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder
This study is trying to see if men and women respond differently to a medication for alcohol use disorder and how factors like trauma and emotions might play a role in that.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06426303 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 18-60 who meet the DSM-V criteria for recent alcohol use disorder.
Not a fit: Patients with significant neurological or psychiatric disorders, or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, sex-specific treatments for individuals with Alcohol Use Disorder.
How similar studies have performed: Other studies have shown promise in exploring sex differences in treatment responses, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Portland, Oregon
- VA Portland Health Care System — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Jazryn Nagum
- Email: vhaporhoffmanlab@va.gov
- Phone: 503-721-7964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.