West Haven, Connecticut 06516


Purpose:

The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial. First, prior to the double-blind trial, the investigators will conduct an open-label trial that will include 5 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) with a follow-up of 4 weeks. Second, after reviewing the safety and efficacy of repeated ketamine treatment from the open-label trial, the investigators will conduct an 8-week, randomized, double-blind, placebo-controlled trial that will include 60 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) plus naltrexone with a follow-up of 4 weeks. The 4-month follow-up session will also occur.


Criteria:

Inclusion Criteria: 1. Male or female veterans, 21-65 years old 2. Current major depressive disorder without psychotic features by DSM-5 (antidepressant regimens can be allowed and changed during the trial) 3. Montgomery- sberg Depression Rating Scale (MADRS) 20 4. A minimum of 4 of 11 current alcohol use disorder symptoms by DSM-5 5. Heavy drinking at least 4 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. 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 dementia or PTSD 4. Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg) 5. Unstable medical condition or allergy to ketamine, midazolam, 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 11. Current use of benzodiazepine 12. Acute narrow-angle glaucoma


NCT ID:

NCT02461927


Primary Contact:

Principal Investigator
Gihyun Yoon, MD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Gihyun Yoon, MD
Phone: (203) 932-5711 ext. 7421
Email: gihyun.yoon@va.gov


Backup Contact:

N/A


Location Contact:

West Haven, Connecticut 06516
United States

Gihyun Yoon, MD
Phone: 203-932-5711
Email: gihyun.yoon@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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