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

NCT05940324 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 709541R01MH133553-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD; Ketamine; Naltrexone; MRI; Brain Imaging; OCD symptoms; Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (3)

Ketamine + Naltrexone

EXPERIMENTAL

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.

Drug: Ketamine; Drug: Naltrexone Pill

Ketamine + Placebo

PLACEBO COMPARATOR

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.

Drug: Ketamine; Other: Placebo pill

Healthy Volunteers

NO INTERVENTION

Healthy volunteers will have one fMRI scan visit.

Interventions

Ketamine DRUG

Ketamine is an FDA-approved dissociative anesthetic.

Also known as: Ketamine Hydrochloride, Ketalar

Ketamine + Naltrexone; Ketamine + Placebo

Naltrexone Pill DRUG

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)

Also known as: Naltrexone

Ketamine + Naltrexone

Placebo pill OTHER

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

Ketamine + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Ages 18-65
• Able to provide informed consent
• current or past use of psychotropic medication
• pregnant or nursing females
• the presence of metal in the body that is contraindicated for MRI scans

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Department of Psychiatry & Behavioral Sciences

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Ketamine; Naltrexone

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Pavithra Mukunda, MS

CONTACT

6504972578; ocdresearch@stanford.edu

Carolyn I Rodriguez, MD, PhD

CONTACT

(650) 723-6158; ocdresearch@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized with a 1:1 allocation to either IV ketamine + oral placebo or IV ketamine + oral opioid antagonist naltrexone

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: February 24, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)