Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02461927
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02461927
Study Brief:
Protocol Section:
NCT02461927