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CompletedPhase 2

Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder

NCT03658330 · VA Connecticut Healthcare System

Closed to entry
Status
Not accepting participants
Phase 2
Phase
5
Target enrolment
Study sites

What it is testing

Summary

To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured over Day 21

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Male or female, 21-65 years old 2. Current major depressive disorder without psychotic features by DSM-5 3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20 4. Current alcohol use disorder by DSM-5 5. Heavy drinking at least 3 times in the past month ('heavy drinking' defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks per day for women) 6. Abstinence from alcohol drinking for \> 5 days prior to ketamine infusion 7. Able to provide written informed consent Exclusion Criteria: 1. Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis) 2. Current or past history of psychotic features or psychotic disorder 3. Current or past history of delirium or dementia 4. Current uncontrolled hypertension (systolic BP \> 170 mm Hg or diastolic BP \> 100 mm Hg) 5. Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician 6. Imminent suicidal or homicidal risk 7. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential 8. Positive opioid or illicit drug screen test (except marijuana) 9. Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study 10. Liver enzymes that are three times higher than the upper limit of normal

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03658330 on ClinicalTrials.gov →

Last updated in the registry 2018-09-07. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits