What is (2R,6R)-hydroxynorketamine studying for neuropathic pain?

This clinical trial is studying the pain relief effects and duration of a single infusion of (2R,6R)-hydroxynorketamine compared with ketamine and saline in adults with chronic neuropathic pain of the extremities. Researchers want to understand how this treatment affects pain intensity, quality, daily activities, and sleep. The study is sponsored by Rush University Medical Center.

Who may be eligible for this neuropathic pain clinical trial?

Adults aged 18 to 75 years with chronic neuropathic pain in the arms or legs lasting more than 3 months may be eligible. Participants must meet certain health criteria including specific BMI and blood pressure ranges and must not have had prior ketamine treatment for pain. Please review eligibility criteria for more details.

Is there any cost to participate in this neuropathic pain clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any personal costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

ID05864053

2R,6R-Hydroxynorketamine a Novel Therapeutic Analgesic for the Treatment of Neuropathic Pain A Randomized Double Blind Cross-Over Trial.

Led by Rush University Medical Center · Updated on 2026-01-07

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a single infusion of 2R,6R-hydroxynorketamine HNK compared to ketamine and saline in adults with chronic neuropathic pain of the extremities lasting more than 3 months. This randomized, double-blind, three-way crossover trial aims to study the pain relief effectiveness and duration of these treatments, as well as their impact on pain qualities, physical function, pain interference, sleep disturbance, and quality of life. Participants will receive three different treatmentsketamine 0.5mgkg, 2R,6R-HNK 0.5mgkg, and salineeach as a 45-minute infusion given in random order with a 5-week interval between infusions over a 15-week period. Five subjects will be assigned to each possible treatment sequence. The study includes a pretreatment evaluation and follow-up assessments at 7, 14, 21, and 35 days after each infusion. During the study, participants will undergo detailed sensory and pain evaluations and complete questionnaires to report their pain and related symptoms. Safety assessments include vital signs, medical history, blood tests, liver function tests, and electrocardiograms before and after each treatment. Participants will continue their usual pain medications and record any additional medication use. The main outcome measured is pain intensity over 35 days, with secondary outcomes including pain qualities and analgesic consumption.

CONDITIONS

Brief Title

(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 75 years with chronic neuropathic pain of the extremities lasting more than 3 months.
Neuropathic pain confirmed by a score of 4 or higher on the 10-item Neuropathic Pain Questionnaire (DN4).
Ability to read and write English to complete study procedures.
Body mass index (BMI) between 18 and 35 kg/m² and weight between 50 and 120 kg.
Blood pressure while lying down between 90 and 145 mmHg systolic and no higher than 90 mmHg diastolic.
Normal or clinically acceptable 12-lead ECG with QTc interval ≤ 450 milliseconds.
Resting pulse rate between 45 and 100 beats per minute.
Clinical laboratory and liver function tests within normal or acceptable ranges.
Willingness to provide written informed consent and follow study rules regarding alcohol, caffeine, and tobacco use.
Agreement to continue scheduled medications for neuropathic pain during the study and use as-needed medications responsibly.

You will not qualify if you...

Suspected increased intracranial or intraocular pressure.
Previous ketamine treatment for chronic pain.
Participation in another clinical study with investigational drugs or devices within 30 days.
Severe medical illnesses that may risk safety or study validity.
Significant acute illness within 2 weeks prior to dosing.
Inability to communicate effectively with research staff.
Known liver disease.
Widespread pain or diagnosis of fibromyalgia.
Current mental illness diagnosis.
Pregnancy.
Allergy to ketamine or any study drug.
Consumption of certain foods or beverages (alcohol, grapefruit, poppy seeds, Brussels sprouts, pomegranate, broccoli, char-grilled meat) within 2 days before drug administration.
Use of tobacco or nicotine products within 4 weeks prior to drug administration.
Poor peripheral venous access.
Any other condition judged by the investigator to preclude participation.

Research Team

Robert J McCarthy, Pharm D

Daniel Torrez, BS

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here