NCT04992624

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Steven E Harte, PhD · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study hypothesizes that: * CBD alone will exert a peripheral anti-inflammatory effect by decreasing levels of Interleukin (IL)-6 * THC alone will modify central nervous system (CNS) pain via decreasing insula to Default Mode Network (DMN) connectivity * CBD plus THC will do both.

Conditions

• Osteoarthritis, Knee
• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Placebo	Placebo drug will be taken similarly to the THC and CBD and be matched to keep the trial blinded. In the event that 2.5 mg capsules of dronabinal capsules become unavailable, an equivalent product will be issued to participants and the comparator and placebo arms will be correspondingly adjusted to preserve blinding. If a participant's dose is not well-tolerated, the participant may initiate dose reductions with the study team. Participants will be instructed to eat a meal or snack greater than one hour after taking study drug.
DRUG	Cannabidiol (CBD)	Epidiolex doses will be 0.37 milliliter (mL) for seven days of treatment and then 0.75 mL two times a day (b.i.d) for the remaining days of this treatment. In the event that 2.5 mg capsules of dronabinal capsules become unavailable, an equivalent product will be issued to participants and the comparator and placebo arms will be correspondingly adjusted to preserve blinding. If a participant's dose is not well-tolerated, the participant may initiate dose reductions with the study team. Participants will be instructed to eat a meal or snack greater than one hour after taking study drug.
DRUG	Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)	Dronabinol Capsules doses will be 2.5 mg b.i.d. for seven days of treatment and then 5 mg b.i.d. for the remaining days of this treatment. In the event that 2.5 mg capsules of dronabinal capsules become unavailable, an equivalent product will be issued to participants and the comparator and placebo arms will be correspondingly adjusted to preserve blinding. If a participant's dose is not well-tolerated, the participant may initiate dose reductions with the study team. Participants will be instructed to eat a meal or snack greater than one hour after taking study drug.

Timeline

• Start date: 2022-02-22
• Primary completion: 2026-10-22
• Completion: 2026-10-31
• First posted: 2021-08-05
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study