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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02461927
Other study ID # MHBB-009-16F
Secondary ID GY 0002
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 1, 2015
Est. completion date October 30, 2023

Study information

Verified date October 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date October 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: - Male or female veterans and civilians, 21-65 years old - Current major depressive disorder without psychotic features by DSM-5 (antidepressant regimens can be allowed and changed during the trial) - Montgomery-Asberg Depression Rating Scale (MADRS) 20 or higher - A minimum of 4 of 11 current alcohol use disorder symptoms by DSM-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 - 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 dementia - Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg) - Unstable medical condition or allergy to ketamine, midazolam, 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 - Current use of benzodiazepine - Acute narrow-angle glaucoma - Severe sleep apnea---clinically determined by a physician

Study Design


Intervention

Drug:
Ketamine + Naltrexone
Subjects in this arm 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 2 injections).
Ketamine + Placebo
Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
Placebo (psychoactive placebo midazolam) + Placebo
Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).

Locations

Country Name City State
United States VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery-Asberg Depression Rating Scale (MADRS) Severity of depression Day 21 (after 4th infusion, 240 minutes)
Primary Time Line Follow Back (TLFB) Rate of complete abstinence from alcohol Day 28
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