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

Phase 2RecruitingNCT05940324

Stanford University150 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Obsessive-Compulsive Disorder

Interventions

KetamineDRUG

Ketamine is an FDA-approved dissociative anesthetic.

Naltrexone PillDRUG

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 pillOTHER

An oral inactive placebo pill will be administered to preserve the blinded nature of the study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry & Behavioral Sciences

Stanford, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 week

Central Contacts

Pavithra Mukunda, MS

CONTACT

6504972578 ocdresearch@stanford.edu

Carolyn I Rodriguez, MD, PhD

CONTACT

(650) 723-6158 ocdresearch@stanford.edu

Data from ClinicalTrials.gov

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