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

25

Participants Needed

1

Research Sites

N/A

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

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 treatments—ketamine 0.5mg/kg, (2R,6R)-HNK 0.5mg/kg, and saline—each 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

Eligible

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.
Not Eligible

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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Each treatment period includes at least 7 days before and 35 days after each infusion

Participants receive randomized infusions of ketamine, (2R,6R)-hydroxynorketamine, and saline in a cross-over design, each infusion lasting 45 minutes. Pain and safety assessments are conducted before and after each infusion.

Multiple visits including 1 infusion visit and follow-up assessments after each infusion

Trial Site Locations

Total: 1 location

1

Rush University Medical Center

Chicago, Illinois, United States, 60612

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Research Team

R

Robert J McCarthy, Pharm D

D

Daniel Torrez, BS

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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Published Research Related To This Trial

The prevalence of neuropathic pain: clinical evaluation compared with screening tools in a community population.

Barbara P Yawn, Peter C Wollan, Toby N Weingarten...

https://pubmed.ncbi.nlm.nih.gov/20849570

Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists.

Steven P Cohen, Anuj Bhatia, Asokumar Buvanendran...

https://pubmed.ncbi.nlm.nih.gov/29870458

Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists.

Eric S Schwenk, Eugene R Viscusi, Asokumar Buvanendran...

https://pubmed.ncbi.nlm.nih.gov/29870457

The use of intravenous infusion or single dose of low-dose ketamine for postoperative analgesia: a review of the current literature.

Julie Jouguelet-Lacoste, Luca La Colla, Dennis Schilling...

https://pubmed.ncbi.nlm.nih.gov/25530168

Ketamine induces rapid and sustained antidepressant-like effects in chronic pain induced depression: Role of MAPK signaling pathway.

Muris Humo, Beyza Ayazgök, Léa J Becker...

https://pubmed.ncbi.nlm.nih.gov/32109506