Recruiting
Phase 2

Ketamine

Sponsor:

Stanford University

Code:

NCT05940324

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Ketamine

Naltrexone Pill

Placebo pill

Study Details

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

Study ID

NCT05940324

Start date

Feb 24, 2024

Status verified date

Apr, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

no intervention: Healthy Volunteers

Healthy volunteers will have one fMRI scan visit.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Pavithra Mukunda, MS

6504972578ocdresearch@stanford.edu

Carolyn I Rodriguez, MD, PhD

(650) 723-6158ocdresearch@stanford.edu

Locations

Department of Psychiatry & Behavioral Sciences

Recruiting

Stanford, California, United States, 94305

Contacts

OCD Research

650-723-4095

More Information

Sponsor

Stanford University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-24.