RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-02
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06426303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-60 years old
  2. * Veteran enrolled in VHA healthcare
  3. * must meet diagnosis for recent alcohol-use disorder (DSM-V)
  4. * willing to return for follow-up visits and can participate for 12-weeks
  5. * must not meet DSM-V criteria for a use disorder other than nicotine
  1. * Clinically significant neurological, endocrine, hepatic, or systemic disease that would compromise safe participation or confound outcomes
  2. * Left-handedness
  3. * Axis-1 psychiatric diagnoses other than anxiety, depression or post-traumatic stress disorder
  4. * Recreational or prescriptive use of psychotropic medications
  5. * Recreational or prescriptive use of opioid medications or have a past or current history of abuse or dependence on opioids
  6. * MRI contraindications (e.g. metal in body)
  7. * Positive urine drug screen, except for nicotine and marijuana, on test days
  8. * Women who are pregnant or breastfeeding
  9. * Participants on hormonal therapy or treatments other than pregnancy contraceptives
  10. * Autoimmune or neurodegenerative diseases that present with neuroinflammation (multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, Parkinson's)
  11. * Current participation in an investigational drug study
  12. * Alcohol group: \< 5 days and \> 3 weeks of abstinence from alcohol
  13. * 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.
  14. * Non-english speaker

Contacts and Locations

Study Contact

Jazryn Nagum
CONTACT
503-721-7964
vhaporhoffmanlab@va.gov

Study Locations (Sites)

VA Portland Health Care System
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Milky Kohno

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-02
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-05-02
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Naltrexone

Additional Relevant MeSH Terms

  • Alcohol Use Disorder