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NCT Number: NCT05940324

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

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

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry & Behavioral Sciences

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

OCD Research

CONTACT

650-723-4095

About this study

The proposed mechanistic trial would be the first to probe the role of ketamine's opioid properties in modulating fronto-striatal circuitry and bringing about reduction of OCD symptoms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria for Participants with OCD:

Inclusion criteria

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

Exclusion criteria

  • prior naltrexone or ketamine use/exposure
  • Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
  • Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
  • the presence of metal in the body that is contraindicated for MRI scans

Eligibility Criteria for Healthy Volunteers:

Inclusion criteria

  • Ages 18-65
  • Able to provide informed consent

Exclusion criteria

  • current or past use of psychotropic medication
  • pregnant or nursing females
  • the presence of metal in the body that is contraindicated for MRI scans

Treatment and study plan

ketamine

Drug

Ketamine is an FDA-approved dissociative anesthetic.

Other names: Ketamine Hydrochloride, Ketalar

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)

Other names: Naltrexone

Placebo pill

Other

An oral inactive placebo pill will be administered to preserve the blinded nature of the study.

Primary outcomes

  1. 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

    Change in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn I Rodriguez, MD, PhD

CONTACT

[email protected]

(650) 723-6158

Pavithra Mukunda, MS

CONTACT

[email protected]

6504972578

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: MKET2

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 11, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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