(2R,6R)-Hydroxynorketamine for Neuropathic Pain
This study is looking at how well (2R,6R)-hydroxynorketamine works to relieve chronic neuropathic pain (nerve pain) in your arms and legs. Researchers will compare it to ketamine and a saline (saltwater) placebo. You might be able to join if you are between 18 and 75 years old, have had chronic nerve pain for over three months, and can read and write English. The study will measure your pain intensity over 35 days to see if (2R,6R)-hydroxynorketamine helps reduce your pain and for how long. The study plans to enroll 25 participants, but its current status is unclear.
- Study design
- This is a randomized, double-blind, three-way crossover study, meaning you will receive each of the three treatments (ketamine, (2R,6R)-hydroxynorketamine, and saline) at different times, and neither you nor your doctors will know which treatment you are receiving. It plans to enroll 25 participants.
- What's involved
- You will be evaluated for at least 7 days before your first treatment and for 35 days after each of your three treatments. Each treatment will involve a 45-minute infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for at least 35 days after each treatment to assess pain intensity and other factors.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05864053
(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain
Recruiting
PHASE1Ages 18–75InterventionalTreatmentRush University Medical CenterInvestigator-initiated
~25 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Ketamine(2R,6R)-hydroxynorketamineSaline
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain intensity
Measured over 35 days
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Asokumar Buvanendran, MD · PRINCIPAL_INVESTIGATOR · Rush University Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Adult patients (18 to 75 years) with an established diagnosis of chronic (\> 3 month) NP of the extremities.
Presence of NP as determined at screening using the 10 item Neuropathic Pain Questionnaire (DN4), with a score of ≥4 required for study inclusion.
Ability to read and write English sufficiently to complete study related procedures.
A body mass index (BMI) (weight \[kg\]/height\[m \]) between 18 and 35 kg/m (inclusive) and weighs between 50 kg and 120 kg (110 - 264 pounds).
Blood pressure with subject is in a supine position for approximately 5 minutes between 90 and 145 mmHg systolic and no higher than 90 mmHg diastolic at baseline.
A 12-lead ECG with no clinically significant abnormality as judged by the Investigator and QTc interval ≤ 450 milliseconds at baseline.
Resting pulse rate between 45 and 100 beats per minute.
Clinical laboratory findings and liver function tests within the normal range, or if outside of the normal ranges, deemed not clinically significant in the opinion of the PI.
Agree to provide written informed consent and comply with the rules regarding consumption of alcohol, caffeinated beverages, and tobacco/nicotine products during the study.
Patients may be taking scheduled or as needed medications for their chronic neuropathic pain and agree to continue taking the scheduled medications throughout the study period.
If the subject experiences pain relief they may elect not to take as needed medications.
Exclusion
Subjects with suspected increased intracranial or intraocular pressure.
Subjects that have previously received ketamine for the treatment of a chronic pain diagnoses.
Previous or current participation in any clinical study with an investigational drug, device, or biologic within 30 days.
Subjects with severe medical illness including (but not limited to) hepatic, cardiovascular, pulmonary, renal, hematologic, endocrine, gastrointestinal, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease that in the opinion of the PI would endanger the safety of the subject or the validity of the study results.
Clinically significant acute illness in the 2 weeks prior to dosing.
Inability to effectively communicate with research staff.
Subjects with known liver disease.
Widespread pain or a diagnosis of fibromyalgia.
Current diagnosis of mental illness.
Pregnancy.
Allergy to ketamine or any study drug.
Consumption of beverages or food that contain alcohol, grapefruit, poppy seeds, Brussel sprouts, pomegranate, broccoli, char-grilled meat within 2 days prior to drug administration.
Use of tobacco or nicotine-containing products within 4 weeks prior to drug administration.
Poor peripheral venous access.
Subjects in the opinion of the PI should not participate in the study.
What this trial measures
- Pain intensity35 days
Area under the pain by time curve