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

September 5, 2018 updated by: Gihyun Yoon, VA Connecticut Healthcare System
To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine + Naltrexone
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).
Drug: Ketamine + Naltrexone
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Day 21
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).
Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obsessive Compulsive Drinking Scale (OCDS)
Time Frame: Day 21
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).
Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Investigators

  • Principal Investigator: Gihyun Yoon, MD, VA Connecticut Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

September 1, 2018

First Submitted That Met QC Criteria

September 1, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GY0004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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