Alcohol Use Disorder, Major Depressive Disorder
Conditions
Keywords
Ketamine, Naltrexone, Depression, Alcohol
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.
Interventions
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).
Sponsors
VA Connecticut Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obsessive Compulsive Drinking Scale (OCDS) | 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). |
Outcome results
None listed