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

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ClinicalTrials.gov Identifier: NCT03658330
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Gihyun Yoon, VA Connecticut Healthcare System

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Alcohol Use Disorder Drug: Ketamine + Naltrexone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Actual Study Start Date : May 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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).




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658330


Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
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Principal Investigator: Gihyun Yoon, MD VA Connecticut Healthcare System

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Responsible Party: Gihyun Yoon, Principal Investigator, VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT03658330     History of Changes
Other Study ID Numbers: GY0004
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gihyun Yoon, VA Connecticut Healthcare System:
Ketamine
Naltrexone
Depression
Alcohol
Additional relevant MeSH terms:
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Disease
Alcoholism
Depressive Disorder
Depression
Depressive Disorder, Major
Alcohol Drinking
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Naltrexone
Ketamine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents