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RECRUITING Phase 2

Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee

NCT04992624 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 200 participants
Start Date 2022-02-22
Est. Completion 2026-10-31
Phase Phase 2

Sponsor

Steven E Harte, PhD

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04992624

The ClinicalTrials.gov registry entry for NCT04992624 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Steven E Harte, PhD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04992624 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial