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Naltrexone for Alcohol Use Disorder and Sex Differences

This study is looking at how Naltrexone, a medication for alcohol use disorder (AUD), works differently in men and women. Researchers want to understand how trauma, inflammation (the body's response to injury or infection), and brain function affect AUD and how Naltrexone might help. You could be eligible if you are 18-60 years old, a veteran enrolled in VHA healthcare, and have an AUD diagnosis. The study will measure changes in your alcohol use, inflammation markers in your blood, and brain activity over 12 weeks to see how effective Naltrexone is for you. The study is currently unclear on its recruitment status.

Study design
This is a 12-week randomized, double-blinded, placebo-controlled study involving 100 participants with alcohol use disorder. Fifty healthy participants will also be included for baseline comparisons.
What's involved
You would participate for 12 weeks, with follow-up visits. Your alcohol use, emotion regulation, and inflammation markers will be assessed, and you will undergo brain imaging.
Compensation
Not stated in the trial record.
Follow-up
Your alcohol use, inflammation markers, and brain function will be measured at baseline and after 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06426303

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

Recruiting
PHASE4Ages 18–60InterventionalBasic science
Milky Kohno
~100 participants
Updated 2024-07-18 on ClinicalTrials.gov
What's tested:Naltrexone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in alcohol use (number of drinking days, amount used per day)
Measured over Baseline and Week 12
+5 more outcomes measured

Conditions

Alcohol Use Disorder

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
Oregon1

Who to contact

Jazryn Nagum
[email protected]
503-721-7964
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18-60 years old
Veteran enrolled in VHA healthcare
must meet diagnosis for recent alcohol-use disorder (DSM-V)
willing to return for follow-up visits and can participate for 12-weeks
must not meet DSM-V criteria for a use disorder other than nicotine

Exclusion

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.
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What this trial measures

  • Change from baseline in alcohol use (number of drinking days, amount used per day)Baseline and Week 12

    Drinking days and average number of weekly standard drinks will be measured at baseline and at follow-up

  • Changes from baseline in peripheral immune biomarkers associated with inflammationBaseline and Week 12

    Plasma samples will be analyzed using a customized, high-sensitivity magnetic bead multiplex assay Luminex system. Samples will be prepared and analyzed to measure peripheral immune markers: interleukin (IL)-1-beta, IL-6, IL-10, tumor necrosis factor (TNF)-alpha, brain-derived neurotrophic factor (BDNF), monocyte chemotactic protein (MCP)-1 and neural cell adhesion molecule (NCAM). Intra-and inter-assay coefficients of variation, as indices of within-and between-assay precision, respectively, will be calculated to examine the reliability of cytokine measurements.

  • Changes in limbic functional connectivityBaseline and Week 12

    Resting-state functional magnetic resonance imaging (rs-fMRI) will be used to assess changes in limbic system connectivity. Correlation coefficients of low-frequency oscillations in the fMRI blood oxygenation level dependent (BOLD) signal between regions and between large-scale resting-state networks in the brain will be z-score transformed. A score of 0 indicates no change while higher or lower scores indicate increased or decreased connectivity, respectively.

  • Changes from baseline in BOLD signal brain activation during an emotion regulation fMRI taskBaseline and Week 12

    The task will assess emotional reactivity and regulation to negative and stressful images. Each event (cue, neutral-look, negative-look, negative-reappraise and rating scale of negative affect) will be modeled using a canonical hemodynamic response function with a time derivative. The contrasts of interest will be Negative-look vs Neutral-look and Negative-look vs Negative-reappraise. Amygdala BOLD signal estimates will be extracted to calculate percent-change.

  • Changes from baseline in emotion regulation assessed with the Difficulty in Emotion Regulation Scale (DERS)Baseline and Week 12

    DERS is a 36-item self-report questionnaire scored on a 5-point scale from 1 (almost never) to 5 (almost always), with total score ranging from 36 to 180. It measures emotion regulation difficulties across six dimensions: 1. Non-acceptance of emotional responses, 2. Difficulties engaging in goal-directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to effective emotion regulation strategies, 6. Lack of emotional clarity. Higher scores suggest greater difficulties in emotion regulation.

  • Changes from baseline in emotion regulation assessed with the Cognitive Emotion Regulation Questionnaire (CERQ)Baseline and Week 12

    CERQ is a 36-item self-report questionnaire that identifies cognitive emotion regulation or cognitive coping strategies used after having experienced negative events or situations. Scores can identify individual strategies to compare with normed scores from various populations. The nine cognitive emotion regulation strategies are measured on a 5-point Likert scale ranging from 1 to 5, with scores being obtained by calculating the mean scores belonging to a particular subscale. Higher subscale scores indicate greater use of a specific cognitive strategy.