Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
NCT ID: NCT05940324
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-02-24
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ketamine + Naltrexone
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.
Ketamine
Ketamine is an FDA-approved dissociative anesthetic.
Naltrexone Pill
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)
Ketamine + Placebo
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.
Ketamine
Ketamine is an FDA-approved dissociative anesthetic.
Placebo pill
An oral inactive placebo pill will be administered to preserve the blinded nature of the study.
Healthy Volunteers
Healthy volunteers will have one fMRI scan visit.
No interventions assigned to this group
Interventions
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Ketamine
Ketamine is an FDA-approved dissociative anesthetic.
Naltrexone Pill
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)
Placebo pill
An oral inactive placebo pill will be administered to preserve the blinded nature of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Ages 18-65
* Able to provide informed consent
Exclusion Criteria
* 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:
* current or past use of psychotropic medication
* pregnant or nursing females
* the presence of metal in the body that is contraindicated for MRI scans
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Stanford University
OTHER
Responsible Party
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Carolyn Rodriguez
Professor
Locations
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Department of Psychiatry & Behavioral Sciences
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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OCD Research
Role: primary
Other Identifiers
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70954
Identifier Type: -
Identifier Source: org_study_id