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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Steven E Harte, PhD
Study ID
NCT04992624
Phase
PHASE2
Status
Recruiting
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Conditions

  • Osteoarthritis of the Knee
  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    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.
  • Cannabidiol (CBD) — DRUG
    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.
  • Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol) — DRUG
    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.

Study Details

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).

Key Dates

Start date
Feb 22, 2022
Status verified
Aug 2025
Primary completion
Oct 22, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo
  • Experimental: Cannabidiol (CBD)
    Up to 150 mg/day.
  • Experimental: Tetrahydrocannabinol (THC)
    Up to 10 mg/day.
  • Experimental: CBD plus THC
    Up to 150 mg/day CBD plus up to 10 mg/day THC.

Primary Outcome Measure

Default mode network (DMN) to insula connectivity via functional connectivity magnetic resonance imaging (fcMRI) [ Time Frame: Day 15, and approximately day 99 of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Jaye Minghine
[email protected]
734-998-7020
Steven Harte, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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