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

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Naltrexone Pill; Other: Placebo pill; Drug: Ketamine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05940324

70954

1R01MH133553-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 3 patient groups, including a placebo group

Ketamine + Naltrexone

Experimental group

Description:

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.

Treatment:

Drug: Ketamine

Drug: Naltrexone Pill

Ketamine + Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ketamine

Other: Placebo pill

Healthy Volunteers

No Intervention group

Description:

Healthy volunteers will have one fMRI scan visit.