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NCT05940324 | RECRUITING | Obsessive-Compulsive Disorder


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

Stanford University

Information provided by (Responsible Party):

Carolyn Rodriguez

Brief Summary:

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

Condition or disease

Obsessive-Compulsive Disorder

Intervention/treatment

Ketamine

Naltrexone Pill

Placebo pill

Phase

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
Actual Study Start Date : 2024-02-24
Estimated Primary Completion Date : 2028-11
Estimated Study Completion Date : 2028-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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

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

Location Details

NCT05940324


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Locations


RECRUITING

United States, California

Department of Psychiatry & Behavioral Sciences

Stanford, California, United States, 94305

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