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

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05940324

Collaborator

National Institute of Mental Health (NIMH) (NIH)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Drug: Ketamine Drug: Naltrexone Pill Other: Placebo pill	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2028

Anticipated Study Completion Date :

Nov 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Ketamine Ketamine is an FDA-approved dissociative anesthetic. Other Names: Ketamine Hydrochloride Ketalar Drug: 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 Names: Naltrexone
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.	Drug: Ketamine Ketamine is an FDA-approved dissociative anesthetic. Other Names: Ketamine Hydrochloride Ketalar Other: Placebo pill An oral inactive placebo pill will be administered to preserve the blinded nature of the study.
No Intervention: Healthy Volunteers Healthy volunteers will have one fMRI scan visit.

Arm

Intervention/Treatment

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.

Drug: Ketamine

Ketamine is an FDA-approved dissociative anesthetic.

Other Names:

Ketamine Hydrochloride

Ketalar

Drug: 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 Names:

Naltrexone

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.

Drug: Ketamine

Ketamine is an FDA-approved dissociative anesthetic.

Other Names:

Ketamine Hydrochloride

Ketalar

Other: Placebo pill

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

No Intervention: Healthy Volunteers

Healthy volunteers will have one fMRI scan visit.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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