Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine, Naltrexone Pill, Placebo pill.
- Who it may be relevant to
- Registry conditions: Obsessive-Compulsive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Ketamine
Ketamine is an FDA-approved dissociative anesthetic. - Drug 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) - Other Placebo pill
An oral inactive placebo pill will be administered to preserve the blinded nature of the study.
Primary outcome measures
- Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [Time frame: Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 week]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Department of Psychiatry & Behavioral Sciences — Stanford
Identifiers
NCT: NCT05940324 · 70954 · 1R01MH133553-01