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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-75
SponsorSteven E Harte, PhD

About this trial

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).

Eligibility criteria

Qualifiers

Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcomes measures

Willingness to participate in a drug intervention trial

Diagnosis of osteoarthritis (OA) of the knee by a medical provider (confirmed by checking medical records)

Chronic knee pain, defined as moderate to severe knee pain for ≥ 6-month duration

Disqualifiers

Individuals who are actively applying for or in litigation for compensation or disability and other aspects associated with potential secondary gain per self-report

Inability to provide written informed consent

Previous total knee arthroplasty

Planned total knee arthroplasty within the time frame of the study

Trial design

Treatments tested in this trial

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

Treatment groups

200 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Steven E Harte, PhD

Lead sponsor

University of Michigan

Sponsor institution

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator