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

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

Detailed Description
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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.

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

Conditions
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Major Depressive Disorder, Alcohol Use Disorder

Intervention / Treatment
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* Drug: Ketamine + Naltrexone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 21-65 years old Current major depressive disorder without psychotic features by DSM-5 Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20 Current alcohol use disorder by DSM-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) Abstinence from alcohol drinking for > 5 days prior to ketamine infusion Able to provide written informed consent Exclusion Criteria: Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis) Current or past history of psychotic features or psychotic disorder Current or past history of delirium or dementia Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg) Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician Imminent suicidal or homicidal risk Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential Positive opioid or illicit drug screen test (except marijuana) Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study Liver enzymes that are three times higher than the upper limit of normal

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine + Naltrexone<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Naltrexone, Depression, Alcohol