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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 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.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07504601
The ClinicalTrials.gov registry entry for NCT07504601 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07504601 reports 0 study locations.
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.
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