Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee
Status:
Not yet recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Richard Harris
Collaborators:
National Center for Complementary and Integrative Health (NCCIH) National Institute on Drug Abuse (NIDA)