Actively Recruiting
(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain
Led by Rush University Medical Center · Updated on 2026-01-07
25
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
Sponsors
R
Rush University Medical Center
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this randomized double blind three way (1:1:1) cross over clinical trial is to evaluate the effectiveness and duration of analgesia of a single infusion of (2R,6R)-HNK 0.5mg/kg compared with ketamine 0.5mg/kg and saline with a 5-week interval between treatments on pain, pain qualities, physical function, pain interference, sleep disturbance and quality of life in subjects with neuropathic pain of the extremities. The questions that this study will address are: 1. What is the analgesic efficacy of (2R,6R)-HNK on pain intensity and pain qualities in patients with chronic (\>3 month) neuropathic pain (NP). 2. What will be the effective duration of a single infusion of (2R,6R)-HNK in patients with NP. 3. Will (2R,6R)-HNK reduce pain related effects including interference in daily activities of life, sleep disturbances and change the qualities of pain reported by patients. Participants will receive each of the three study drugs in a random order at 5-week intervals over a 15 week period. The drug will be administered as a 45-minute infusion. Participants will complete quantitative sensory and pain evaluations and complete patient reported pain outcomes prior to receiving the first study drug and at 7, 14 and 21 and 35 days following study drug administration.
CONDITIONS
Official Title
(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain
Who Can Participate
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 kg and 120 kg
- Blood pressure while lying down between 90 and 145 mmHg systolic and no higher than 90 mmHg diastolic
- Resting pulse rate between 45 and 100 beats per minute
- Normal or clinically acceptable lab and liver function test results
- Normal 12-lead ECG with QTc interval 450 milliseconds or less
- Willingness to provide informed consent and follow study rules on alcohol, caffeine, and tobacco use
- Agreement to continue scheduled pain medications during the study
- Option to reduce as-needed pain medications if pain relief occurs
You will not qualify if you...
- Suspected increased pressure inside the skull or eyes
- Previous ketamine treatment for chronic pain
- Participation in another clinical trial with investigational drugs or devices within 30 days
- Severe medical illnesses affecting liver, heart, lungs, kidneys, blood, hormones, digestive system, immune system, skin, nervous system, cancer, or mental health that could affect safety or study results
- Acute illness within 2 weeks before dosing
- Inability to communicate effectively with research staff
- Known liver disease
- Widespread pain or diagnosis of fibromyalgia
- Current mental illness
- Pregnancy
- Allergy to ketamine or any study drug
- Consumption of alcohol or certain foods (grapefruit, poppy seeds, Brussel sprouts, pomegranate, broccoli, char-grilled meat) within 2 days before drug administration
- Use of tobacco or nicotine products within 4 weeks before drug administration
- Poor vein access
- Any other condition judged by the investigator as unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
R
Robert J McCarthy, Pharm D
CONTACT
D
Daniel Torrez, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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