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Recruiting Phase 2 NCT05940324

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

Phase 2 – studying effectiveness and dosage
Conditions: Obsessive-Compulsive Disorder

Sponsor: Stanford University

trial.available_in: БГ
Overview
The purpose of this study is to understand how ketamine works in the brain to bring about a reduction in OCD symptoms.
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.
Who can participate
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
Interventions
Ketamine
DRUG
Naltrexone Pill
DRUG
Placebo pill
OTHER
Locations 1
United States (1)
Department of Psychiatry & Behavioral Sciences
Stanford , California
OCD Research
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
24.02.2024
Completion date
01.11.2028
Registry ID
NCT05940324
Source
clinicaltrials.gov
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