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Opioid Receptor Antagonist

Naltrexone for Alcoholism (ABSTAIN Trial)

Phase 4
Recruiting
Research Sponsored by Milky Kohno
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-60 years old
Be between 18 and 65 years old
Must not have
Women who are pregnant or breastfeeding
Autoimmune or neurodegenerative diseases that present with neuroinflammation (multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, Parkinson's)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Awards & highlights

Summary

This trial aims to find specific markers that may make people more likely to develop Alcohol Use Disorder (AUD) based on their gender. It also wants to see how treatment responses differ between males and females with

Who is the study for?
This trial is for individuals with Alcohol Use Disorder (AUD) who are interested in how trauma and sex differences affect their condition. Participants will undergo various assessments, provide biological samples, take a daily study drug or placebo for 12 weeks, and attend regular follow-up exams.
What is being tested?
The trial tests Naltrexone's effectiveness in reducing alcohol cravings and promoting abstinence in AUD patients. It explores the impact of trauma on emotion regulation, inflammation, brain function, and whether treatment effects differ between sexes.
What are the potential side effects?
Naltrexone may cause nausea, headache, dizziness, fatigue or sleep disturbances. Some people might experience anxiety or irritability. Side effects can vary based on individual reactions to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have an autoimmune or neurodegenerative disease like MS, ALS, Alzheimer's, or Parkinson's.
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I have a psychiatric condition that is not anxiety, depression, or PTSD.
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I use medication for mental health reasons.
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I use opioids for pain or have had opioid addiction issues.
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I am on hormonal therapy not related to birth control.
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I have liver disease needing treatment or very high liver enzyme levels, or a condition affecting how my body handles medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in alcohol use (number of drinking days, amount used per day)
Changes from baseline in BOLD signal brain activation during an emotion regulation fMRI task
Changes from baseline in emotion regulation assessed with the Cognitive Emotion Regulation Questionnaire (CERQ)
+3 more
Secondary outcome measures
Change from baseline in craving (include craving measures/questionnaires)
Change from baseline in neuropsychological testing scores
Differences in baseline trauma exposure (composite score)

Side effects data

From 2011 Phase 4 trial • 165 Patients • NCT00006489
24%
Nausea
12%
Headache
12%
Cold
10%
Dry Mouth
10%
Fatigue
7%
Gastrointestinal Issues
7%
Muscle Aches
7%
Vomiting
7%
Serious Suicidal Ideation
5%
Diarrhea
5%
Constipation
5%
Stomach Virus
5%
Changes to Vision
5%
Loose Stool
5%
Increased Irritability
5%
Sedation
5%
Stomach Pain
5%
Increased Bowel Movements
2%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naltrexone + Supportive Counseling
Naltrexone + CBT (Prolonged Exposure Therapy)
Placebo + CBT (Prolonged Exposure Therapy)
Placebo + Supportive Counseling

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Alcohol Use Disorder (AUD)Experimental Treatment1 Intervention
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.
Group II: Healthy ControlsActive Control1 Intervention
Baseline measures will be taken but controls will not continue to the drug trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
2005
Completed Phase 4
~2420

Find a Location

Who is running the clinical trial?

Milky KohnoLead Sponsor
Portland VA Medical CenterFED
42 Previous Clinical Trials
7,704 Total Patients Enrolled
2 Trials studying Alcoholism
76 Patients Enrolled for Alcoholism
~67 spots leftby Dec 2028
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