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

Obsessive-Compulsive Disorder Clinical Trial

— MKET2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940324
• Other study ID #: 70954
• Secondary ID: 1R01MH133553-01
• Status: Recruiting
• Phase: Phase 2
• Start date: February 24, 2024
• Est. completion date: November 2028

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Pavithra Mukunda, MS
• Phone: 6504972578
• Email: ocdresearch[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2028
• Est. primary completion date: November 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Drug:
• 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)

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

Locations

Country	Name	City	State
United States	Department of Psychiatry & Behavioral Sciences	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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