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

NCT ID: NCT03658330

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-06-30

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.

Conditions

Major Depressive Disorder; Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Ketamine + Naltrexone

Intervention Type: 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).

Interventions

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 Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Connecticut Healthcare System

FED

Sponsor Role: lead

Responsible Party

Gihyun Yoon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gihyun Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System

Other Identifiers

GY0004

Identifier Type: -

Identifier Source: org_study_id