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

Brief Summary

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

Intervention / Treatment

  • Ketamine + Naltrexone (DRUG)
    Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection).

Condition or Disease

  • Major Depressive Disorder
  • Alcohol Use Disorder

Phase

  • Phase 2
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 21 Years to 65 Years
    Enrollment: 5 (ACTUAL)
    Funded by: U.S. Fed
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: May 01, 2016 ACTUAL
    Primary Completion: Oct 01, 2016 ACTUAL
    Completion Date: Jun 01, 2018 ACTUAL
    Study First Posted: Sep 05, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 05, 2018

    Sponsors / Collaborators

    Responsible Party: N/A

    The primary goal of this proposal is to test naltrexone plus repeated ketamine treatment for major depressive disorder and alcohol use disorder in an open-label trial.

    Participant Groups

    • Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection).

    Eligibility Criteria

    Sex: All
    Minimum Age: 21
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Response is defined as a ≥ 50% improvement from baseline in MADRS scores. The MADRS has a total range of 0-60. Higher scores represent a worse outcome (i.e., more depression).

    Secondary Outcomes
    • The Obsessive Compulsive Drinking Scale is designed to assess alcohol craving and consumption. The scale has a total score range of 0-56. Higher scores represent a worse outcome (i.e., more alcohol problems).

    More Details

    NCT Number: NCT03658330
    Other IDs: GY0004
    Study URL: https://clinicaltrials.gov/study/NCT03658330
    Last updated: Sep 29, 2023