Background:
Opioid drugs are often prescribed for acute and chronic pain. But these drugs are addictive, and they lead to more than 14,000 overdose deaths in the United States each year. Researchers want to find new drugs that relieve pain but are not addictive. This study will test whether a single dose of an experimental drug called (2R,6R)-hydroxynorketamine (HNK) can help reduce short term pain in healthy adults. HNK is related to ketamine. Studies suggest HNK might be as effective as ketamine at reducing pain but that it might have fewer side effects. In this study we will test how HNK affects pain and emotion. The results of this study may help us understand whether HNK has pain relieving effects and how it works in the brain, which could inform future pain treatments.
Objective:
To test the study drug \[(2R,6R)-hydroxynorketamine (HNK)\] for treating acute pain in healthy people.
Eligibility:
Healthy people aged 18 to 60 years.
Design;
Up to 92 healthy volunteers between 18 and 60 years old without chronic pain or psychiatric conditions will participate in the study. The study will take place at the NIH Clinical Center in Bethesda, Maryland. Each participant s involvement will last up to two months. The overall study is expected to last about three years (36 months).
The study has 2 parts.
In part 1, participants will have up to 2 clinic visits. They will be screened and have blood draws to make sure they're eligible for the study. They will complete sensory testing and have MRI brain scans.
Sensory testing involves feeling and rating painful and non-painful sensations. These may include hot or cold temperatures, pinches or squeezes, and being touched with brushes or pinpricks.
Eligible participants will have an imaging scan that shows brain activity: During the scan, they will rate heat, hear pleasant or unpleasant sounds, and view unpleasant or pleasant pictures.
After completing part 1, eligible participants will be invited to part 2, which includes overnight stays at NIH.
In part 2, participants will be assigned to either a treatment group or a no-treatment group.
The treatment group will have 2 overnight visits of 2 nights each. The visits will be 1 to 3 weeks apart. For one of the visits, treatment group participants will receive the study drug HNK. For the other visit, they will receive a placebo. A placebo looks just like the study drug but contains no medicine. HNK and placebo are given through a tube inserted into a vein in the arm. The sensory tests, blood draws, and MRI scans will be repeated at each visit. Participants will not be told whether they got the drug or placebo on each visit.
The nontreatment group will have 1 overnight visit. They will not receive the drug or placebo. The sensory tests, blood draws, and MRI scans will be repeated.
Participants cannot drink alcohol, use recreational drugs, or take certain other kinds of medicine or supplements during the study.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Aged 18-60 years
In good general health as evidenced by medical history
Current use of disallowed concomitant medications.
Presence of ferromagnetic devices or any devices that could pose a risk relating to the safety of the fMRI procedure, including implanted cardiac pacemaker or auto-defibrillator, insulin pump, ferromagnetic metal in the cranial cavity or eye (e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body), and irremovable body piercings.
Pregnancy or lactation.
Has a clinically important acute or active chronic disease
Crossover
(2R,6R)-Hydroxynorketamine
DrugExperimental, non opioid ketamine metabolite administered as a single intravenous infusion at a dose of 0.5 mg/kg over approximately 40 minutes to evaluate analgesic effects in acute experimental pain.
Placebo
DrugIntravenous saline solution matched in volume and administration schedule to the active drug, administered as a single infusion over approximately 40 minutes.
Pain ratings during quantitative sensory testing (QST)
Change in pain intensity ratings in response to experimentally induced nociceptive stimuli during quantitative sensory testing (QST), comparing (2R,6R)-hydroxynorketamine (HNK) with placebo in a randomized, double blind crossover design, controlling for baseline pain sensitivity.
Safety and tolerability
Incidence and nature of adverse events; changes in vital signs, weight and body mass index, physical examination findings, clinical laboratory results, and electrocardiogram (ECG) parameters following HNK compared with placebo.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
