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

Last updated: December 17, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

2

Condition

Obsessive-compulsive Disorder

Kleptomania

Anxiety Disorders

Treatment

Placebo pill

Naltrexone Pill

Ketamine

Clinical Study ID

NCT05940324
70954
1R01MH133553-01
1R01MH133553
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 fastingprior to the Experimental Session, not enroll in any other interventional clinicaltrials during the duration of the study, and commit to medication study procedures.

  • Able to provide informed consent

Exclusion

Exclusion Criteria:

  • prior naltrexone or ketamine use/exposure

  • Any current or past medical/psychiatric condition that makes participation unsafe inthe opinion of the investigator or study physician

  • Pregnant or nursing, or able to become pregnant and are not practicing an effectivemeans 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

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Placebo pill
Phase: 2
Study Start date:
February 24, 2024
Estimated Completion Date:
November 30, 2028

Study Description

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.

Connect with a study center

  • Department of Psychiatry & Behavioral Sciences

    Stanford, California 94305
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.