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NCT07504601 · ClinicalTrials.gov registry record · Phase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
A Phase 2 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Not yet
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT07504601: Clinical Trial Phase 2 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
NCT07504601 is a Phase 2 study that has not yet begun recruiting, run by National Center for Complementary and Integrative Health (NCCIH). The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07504601, a Phase 2 study, has not yet begun recruiting, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
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 inc
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG (2R,6R)-Hydroxynorketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 2 |
What is known before NCT07504601 opens enrollment
NCT07504601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07504601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07504601 about?
NCT07504601 is a clinical study titled "Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers". 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 singl...
What is the current status of trial NCT07504601?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2026-07-15. Estimated completion is 2031-12-31.
What interventions are being tested in trial NCT07504601?
The interventions under investigation include: Placebo (DRUG), (2R,6R)-Hydroxynorketamine (DRUG).
Who is sponsoring clinical trial NCT07504601?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07504601's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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