Clinical TrialObsessive-Compulsive Disorder (OCD)KetaminePlaceboKetaminePlaceboRecruiting

Examining Mu Opioid Mechanisms of Ketamine’s Rapid Effects in OCD (MKET2) (MKET2)

This Phase II parallel assignment interventional trial (n=150) is conducted by Stanford University. The study aims to comprehend how ketamine functions in the brain to reduce symptoms of Obsessive-Compulsive Disorder (OCD).

Target Enrollment
150 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, quadruple-blind, parallel mechanistic trial comparing IV ketamine (0.5 mg/kg single infusion) with oral naltrexone 50 mg versus oral placebo in adults with OCD; fMRI acquired before, during, and after infusion.

Primary aim is to probe the role of ketamine's opioid properties in modulating fronto-striatal circuitry and reducing OCD symptoms; a healthy volunteer cohort undergoes one fMRI visit for comparison.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine + Naltrexone

experimental

OCD patients receive a single IV ketamine infusion (0.5 mg/kg) with oral naltrexone 50 mg given before infusion; fMRI before, during, and after infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Single infusion; fMRI before/during/after infusion.

  • Placebo
    via Oral• single dose

    Naltrexone 50 mg oral given before infusion.

Ketamine + Placebo

inactive

OCD patients receive a single IV ketamine infusion (0.5 mg/kg) with an oral inactive placebo pill given before infusion; fMRI before, during, and after infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Single infusion; fMRI before/during/after infusion.

  • Placebo
    via Oral• single dose

    Oral inactive placebo pill given before infusion.

Healthy volunteers

waitlist

Healthy volunteers undergo one fMRI scan visit; no drug intervention.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • OCD participants — Inclusion:
  • Ages 18-65
  • Meet criteria for OCD diagnosis
  • Failed at least 1 prior trial of standard first-line OCD treatment
  • Agree to lifestyle modifications: comply with fasting requirements prior to the Experimental Session; not enroll in other interventional clinical trials during the study; commit to medication study procedures
  • Able to provide informed consent
  • Healthy volunteers — Inclusion:
  • Ages 18-65
  • Able to provide informed consent

Exclusion Criteria

  • OCD participants — Exclusion:
  • Prior naltrexone or ketamine use/exposure
  • Any current or past medical or psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
  • Pregnant or nursing, or able to become pregnant and not practicing effective birth control
  • Presence of metal in the body that is contraindicated for MRI scans
  • Healthy volunteers — Exclusion:
  • Current or past use of psychotropic medication
  • Pregnant or nursing females
  • Presence of metal in the body that is contraindicated for MRI scans

Study Details

Locations

Department of Psychiatry & Behavioral Sciences — Stanford, California, United States

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