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NCT04992624 · ClinicalTrials.gov registry record · Phase 2
Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee
A Phase 2 study of Osteoarthritis, Knee and Osteoarthritis of the Knee, sponsored by Steven E Harte, PhD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04992624: Recruiting Phase 2 study of Osteoarthritis, Knee and Osteoarthritis of the Knee, sponsored by Steven E Harte, PhD.
NCT04992624 is a Phase 2 study of Osteoarthritis, Knee and Osteoarthritis of the Knee that is actively recruiting participants, run by Steven E Harte, PhD. The registered enrollment target is 200 participants, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04992624, a Phase 2 study of Osteoarthritis, Knee and Osteoarthritis of the Knee, is actively recruiting participants, sponsored by Steven E Harte, PhD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial is being done to better understand how daily treatment with Tetrahydrocannabinol (THC), Cannabidiol (CBD), or the combination of CBD plus THC affects knee osteoarthritis pain and other related symptoms. Consented participants will have a screening period and visit (up to 30 days to treatment start). If participants pass the screening phase, they will be randomly assigned to take one of the investigational study drugs. For this study, participants will not know when or if they are taking CBD, THC, THC plus CBD, and when or if taking placebo. Clinical pain will be assessed at multiple times throughout the study, and eligibility will be re-assessed at two weeks into the treatment period. It is possible that subjects will not be able to participate in the study after 14 days of of treatment. The treatment period will take approximately 16 weeks and then a follow-up period for approximately 2 weeks. In addition to treatment, participants will have clinical assessments, blood draws, questionnaires, daily pain diaries, sensory testing, as well as have functional connectivity magnetic resonance imaging (fcMRI).
Primary Outcome
Functional connectivity difference maps of insula to DMN connectivity using Independent Component Analysis and seed based connectivity. A reduction in the Z-score as a result of treatment will serve as the primary outcome measure.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cannabidiol (CBD)
- DRUG Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-02-22 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What NCT04992624 shows while recruiting
NCT04992624 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04992624 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04992624 about?
NCT04992624 is a clinical study titled "Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee". This clinical trial is being done to better understand how daily treatment with Tetrahydrocannabinol (THC), Cannabidiol (CBD), or the combination of CBD plus THC affects knee osteoarthritis pain and other related symptoms. Consented participants will have a screening period and visit (up to 30 days...
What is the current status of trial NCT04992624?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2022-02-22. Estimated completion is 2026-10-31.
What conditions does trial NCT04992624 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Osteoarthritis of the Knee.
What interventions are being tested in trial NCT04992624?
The interventions under investigation include: Placebo (DRUG), Cannabidiol (CBD) (DRUG), Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol) (DRUG).
Who is sponsoring clinical trial NCT04992624?
This trial is sponsored by Steven E Harte, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04992624 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04992624's enrollment target sits among peer trials
200 32nd of 112 higher than 78 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee 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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