Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University
About this trial
The purpose of this study is to understand how ketamine works in the brain to bring about a reduction in OCD symptoms.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine
DrugKetamine is an FDA-approved dissociative anesthetic.
Naltrexone Pill
DrugNaltrexone 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
Other interventionAn oral inactive placebo pill will be administered to preserve the blinded nature of the study.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Ketamine + NaltrexoneExperimental treatment 2 interventions
Group B: Ketamine + PlaceboPlacebo comparator 2 interventions
Group C: Healthy VolunteersNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov