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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ketamine
Naltrexone Pill
Placebo pill
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, Ketamine, Naltrexone, MRI, Brain Imaging, OCD symptoms, Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

    Ketamine + Naltrexone

    Ketamine + Placebo

    Healthy Volunteers

    Arm Description

    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.

    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.

    Healthy volunteers will have one fMRI scan visit.

    Outcomes

    Primary Outcome Measures

    Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 3, 2023
    Last Updated
    September 27, 2023
    Sponsor
    Stanford University
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05940324
    Brief Title
    Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
    Acronym
    MKET2
    Official Title
    Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2028 (Anticipated)
    Study Completion Date
    November 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder
    Keywords
    OCD, Ketamine, Naltrexone, MRI, Brain Imaging, OCD symptoms, Obsessive-Compulsive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomized with a 1:1 allocation to either IV ketamine + oral placebo or IV ketamine + oral opioid antagonist naltrexone
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketamine + Naltrexone
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Ketamine + Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Healthy Volunteers
    Arm Type
    No Intervention
    Arm Description
    Healthy volunteers will have one fMRI scan visit.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    Ketamine Hydrochloride, Ketalar
    Intervention Description
    Ketamine is an FDA-approved dissociative anesthetic.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone Pill
    Other Intervention Name(s)
    Naltrexone
    Intervention Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Placebo pill
    Intervention Description
    An oral inactive placebo pill will be administered to preserve the blinded nature of the study.
    Primary Outcome Measure Information:
    Title
    Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
    Description
    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.
    Time Frame
    Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pavithra Mukunda, MS
    Phone
    6504972578
    Email
    ocdresearch@stanford.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carolyn I Rodriguez, MD, PhD
    Phone
    (650) 723-6158
    Email
    ocdresearch@stanford.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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