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NCT Number: NCT06575075

Pilot Study of RR-HNK in OCD

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

Recruiting

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University School of Medicine

Palo Alto, California, 94305, United States

Location status: Recruiting

Location contact

Daniel Bello, BS

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RR-HNK/Hydroxynorketamine

Drug

(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine and a glutamate AMPA receptor antagonist.

Other names: (2R,6R)-Hydroxynorketamine

Placebo

Drug

Sterile Saline

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Izzy Vo, BS

CONTACT

[email protected]

650-723-4095

Sponsors and collaborators

Lead sponsor

Carolyn Rodriguez

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: (HNKO)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 28, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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