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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial 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 two weeks 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). This studies primary hypothesis is that CBD alone will exert a peripheral anti-inflammatory effect shown through decreases in circulating levels of Interleukin-6 (IL-6), THC alone will modify central nervous system (CNS) pain processing via decreased insula to Default Mode Network (DMN) connectivity, and CBD plus THC will do both.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04620512
Study type Interventional
Source University of Michigan
Contact Anna Piasecki
Phone 734-998-7020
Email panna@umich.edu
Status Not yet recruiting
Phase Phase 2
Start date January 2021
Completion date October 2025
View Details
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