Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2) (NCT05940324) | Clinical Trial Compass
RecruitingPhase 2
Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
United States150 participantsStarted 2024-02-24
Plain-language summary
The purpose of this study is to understand how ketamine works in the brain to bring about a reduction in OCD symptoms.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Timeframe: Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 week