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

Phase 2

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Ketamine; Other: Placebo pill; Drug: Naltrexone Pill

• Registration Number: NCT05940324
• Lead Sponsor: Stanford University

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Study Start: 2024-02-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine + Placebo	Placebo pill	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.
Ketamine + Naltrexone	Naltrexone Pill	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.
Ketamine + Naltrexone	Ketamine	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.
Ketamine + Placebo	Ketamine	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.

Primary Outcome Measures

Name	Time	Method
Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)	Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 week	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.

Trial Locations

Locations (1)

Department of Psychiatry & Behavioral Sciences; 🇺🇸 Stanford, California, United States