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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 1, 2018
First Posted Date  ICMJE September 5, 2018
Last Update Posted Date September 7, 2018
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2018)
Response (≥ 50% improvement from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores [ Time Frame: Day 21 ]
Severity of depression
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2018)
Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: Day 21 ]
Alcohol craving and consumption
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Official Title  ICMJE 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Alcohol Use Disorder
Intervention  ICMJE 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).
Study Arms  ICMJE 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).
Intervention: Drug: Ketamine + Naltrexone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2018)
5
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03658330
Other Study ID Numbers  ICMJE GY0004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gihyun Yoon, VA Connecticut Healthcare System
Study Sponsor  ICMJE VA Connecticut Healthcare System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gihyun Yoon, MD VA Connecticut Healthcare System
PRS Account VA Connecticut Healthcare System
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP