Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

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

Open-label, single-group Phase II study (n=5) of IV ketamine 0.5 mg/kg weekly ×4 plus a single IM naltrexone 380 mg injection for patients with major depressive disorder and alcohol use disorder.

Target Enrollment
5 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This open-label single-group Phase II study evaluated repeated IV ketamine (0.5 mg/kg weekly for four infusions) combined with a single IM naltrexone 380 mg injection in participants with major depressive disorder and comorbid alcohol use disorder.

Primary objectives were to assess rapid antidepressant effects and changes in alcohol consumption; safety and tolerability were monitored throughout the treatment course.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Ketamine + Naltrexone

experimental

Open-label single-group treatment: IV ketamine infusions weekly ×4 plus single IM naltrexone injection.

Interventions

  • Ketamine0.5 mg/kg
    via IV• weekly• 4 doses total

    IV ketamine 0.5 mg/kg per infusion, 4 infusions total.

  • Compound380 mg
    via IM• single dose• 1 doses total

    IM naltrexone 380 mg, single injection.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion 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 (≥ 5 standard drinks per day for men; ≥ 4 for women)
  • 6. Abstinence from alcohol drinking for > 5 days prior to ketamine infusion
  • 7. Able to provide written informed consent

Exclusion Criteria

  • 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

Study Details

Locations

United States

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