Steven E Harte, PhD
Steven E Harte, PhD
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).
Osteoarthritis, Knee
Osteoarthritis of the Knee
Placebo
Cannabidiol (CBD)
Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)
PHASE2
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 200 participants |
Masking : | DOUBLE |
Masking Description : | Some of the treatment phase will be blinded by the study team. |
Primary Purpose : | OTHER |
Official Title : | Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee |
Actual Study Start Date : | 2022-02-22 |
Estimated Primary Completion Date : | 2026-10-22 |
Estimated Study Completion Date : | 2026-10-31 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 21 Years to 75 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Michigan
Ann Arbor, Michigan, United States, 48109