Pilot Study of RR-HNK in OCD ((HNKO))

March 3, 2026 updated by: Carolyn Rodriguez

A Double-blind, Placebo-controlled Study to Determine the Safety and Feasibility of Two Doses of Intravenous (2R, 6R)-Hydroxynorketamine (RR-HNK) in Adults With Obsessive-Compulsive Disorder

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This protocol examines the safety and efficacy of 2 dosage levels of intravenous RR-HNK administration in individuals with OCD.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
          • Daniel Bello, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 18-65
  • Meet the criteria for OCD diagnosis
  • Failed at least 1 prior trial of standard first-line OCD treatment (e.g. SRI/CBT) or or had refused these treatments for individual reasons
  • Agree to the following lifestyle modifications: comply with requirements for fasting prior to --the infusion 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:

  • Allergy or hypersensitivity to ketamine
  • 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
  • Lifetime history of deep brain stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.25 mg/kg RR-HNK
OCD patients in this arm will receive 0.25mg/kg of RR-HNK - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.
Drug: RR-HNK/Hydroxynorketamine
(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine and a glutamate AMPA receptor antagonist.
Other Names:
  • (2R,6R)-Hydroxynorketamine
Experimental: 0.5 mg/kg RR-HNK
OCD patients in this arm will receive 0.5mg/kg of RR-HNK - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.
Drug: RR-HNK/Hydroxynorketamine
(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine and a glutamate AMPA receptor antagonist.
Other Names:
  • (2R,6R)-Hydroxynorketamine
Placebo Comparator: Placebo (Sterile Saline)
OCD patients in this arm will receive sterile saline - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.
Drug: Placebo
Sterile Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame: Baseline (Visit 3) to Week 1 (Visit 8), 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.
Baseline (Visit 3) to Week 1 (Visit 8), up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carolyn Rodriguez

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Carolyn Rodriguez, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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