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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05940324
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ketamine — DRUG
    Ketamine is an FDA-approved dissociative anesthetic.
  • Naltrexone Pill — DRUG
    Naltrexone is an oral opioid antagonist approved by the Food and Drug Administration (FDA) to treat both alcohol use disorder (AUD) and opioid use disorder (OUD)
  • Placebo pill — OTHER
    An oral inactive placebo pill will be administered to preserve the blinded nature of the study.

Study Details

The purpose of this study is to understand how ketamine works in the brain to bring about a reduction in OCD symptoms.

Key Dates

Start date
Feb 24, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine + Naltrexone
    OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion. fMRI will be acquired before, during, and after infusion. Oral naltrexone 50 mg will be administered before the infusion.
  • Placebo Comparator: Ketamine + Placebo
    OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion. fMRI will be acquired before, during, and after infusion. An oral inactive placebo will be administered before the infusion.
  • No Intervention: Healthy Volunteers
    Healthy volunteers will have one fMRI scan visit.

Primary Outcome Measure

Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Psychiatry & Behavioral SciencesStanfordCalifornia94305
OCD Research
650-723-4095

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By research site
Department of Psychiatry & Behavioral Sciences· Stanford, CA

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