Recruiting

Alcohol Use Disorder

Sponsor:

Milky Kohno

Code:

NCT06426303

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Naltrexone

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder

Study ID

NCT06426303

Start date

May 2, 2024

Status verified date

Jul, 2024

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Naltrexone

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

Primary outcome measure

  • Change from baseline in alcohol use (number of drinking days, amount used per day) [ Time Frame: Baseline and Week 12 ]
  • Changes from baseline in peripheral immune biomarkers associated with inflammation [ Time Frame: Baseline and Week 12 ]
  • Changes in limbic functional connectivity [ Time Frame: Baseline and Week 12 ]
  • Changes from baseline in BOLD signal brain activation during an emotion regulation fMRI task [ Time Frame: Baseline and Week 12 ]
  • Changes from baseline in emotion regulation assessed with the Difficulty in Emotion Regulation Scale (DERS) [ Time Frame: Baseline and Week 12 ]
  • Changes from baseline in emotion regulation assessed with the Cognitive Emotion Regulation Questionnaire (CERQ) [ Time Frame: Baseline and Week 12 ]

Central Contacts and Locations

Central contacts

Jazryn Nagum

503-721-7964vhaporhoffmanlab@va.gov

Locations

VA Portland Health Care System

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jazryn Nagum

503-721-7964vhaporhoffmanlab@va.gov

More Information

Sponsor

Milky Kohno

Last update posted

Jul 18, 2024

Last verified

Jul, 2024

Keywords

  • Naltrexone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milky Kohno on 2024-07-18.