Washington State University
Spokane, Washington, 99202, United States
NCT Number: NCT07087938
For this quantitative study, the investigators will collect data on human safety and side-effects of Cannabichromene (CBC) and whether CBC reduces blood inflammatory markers and Rheumatoid Arthritis (RA) disease activity. The participants will participate in an ABAB design with 2 doses of CBC across the A phases. They will attend 5 in-person clinic visits where they will have physical evaluations, complete self-report forms, and have blood drawn for the following tests: hs-CRP, ESR, IL-6, TNF, Complete Blood Count [CBC], and CMP.
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Notify Me21 year and older
All sexes
Interventional
Phase 1 / Phase 2
Spokane, Washington, 99202, United States
Due to their anti-inflammatory effects, cannabinoids have been considered as a potential therapy for the treatment of rheumatic diseases in humans. However, there is not yet significant evidence for the efficacy of cannabinoid-based treatments for rheumatoid arthritis, even though it is included in the list of eligible conditions for medical cannabis in Canada and many US states. In this study, the investigators propose to examine the safety and human behavioral pharmacology of CBC:
No statistical hypotheses have been developed for Aims 1 and 2 as they are descriptive in nature. Aim 3 has the statistical hypothesis embedded within it. These are reiterated below:
Aim 1: Assess human safety of CBC through a count of the number of treatment-related adverse events experienced by participants. This is a descriptive aim and therefore does not have an associated hypothesis.
Aim 2: Assess human safety of CBC through measurement of blood markers indicating organ function. This is a descriptive aim wherein the investigators will provide a qualitative description of changes in blood markers during treatment; it therefore does not have an associated hypothesis.
Aim 3: Determine if CBC reduces blood inflammatory markers and overall rheumatoid arthritis disease activity (as measured by the DAS28), across 2 dosages (400mg and 600mg CBC daily), each administered for an 8-week period. The investigators hypothesize that CBC will yield lower levels of inflammatory markers and overall disease activity during the treatment period and that levels of inflammatory markers will return to baseline at the 2-week follow-up for both of the doses.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be assigned (using block randomization) to begin with one of the two study doses of CBC (400mg or 600mg). Participants will be blinded to dose. They will be asked to take half of their dose in the morning and half in the evening. Participants will be administered dose one for eight weeks. After this, participants will have a two-week timeframe where they will be asked not to take any study medication and to continue refraining from cannabis use, thus providing a washout period. Then, at visit three, they will receive dose two and will take it for eight weeks, concluding the study with another two-week washout period. At each clinic visit participants will complete assessments (self-report and physical examination), urine, and blood samples.
Other names: CAS Number: 20675-51-8, CBC, NSC 291831
Time frame: 20 Weeks
Observed Adverse events
Time frame: 20 Weeks
Observed Serious adverse events
Time frame: 20 Weeks
Participant self-report of side-effects
Time frame: 20 Weeks
Safety focused blood marker levels aggregated through Comprehensive Metabolic Panel (CMP) during the treatment and post treatment phases.
Time frame: 20 Weeks
Safety focused blood marker levels aggregated through Complete Blood Count (CBC) during the treatment and post treatment phases.
Time frame: 20 Weeks
Overall Rheumatoid Arthritis disease activity as assessed by the DAS28 (Disease Activity Score in 28 joints) tool across 2 dosages (400mg and 600mg daily), administered for 8 weeks per dose.
Time frame: 20 Weeks
This will be measured across 2 dosages (400mg and 600mg daily), administered for 8 weeks per dose.
This will be determined through the collection of inflammation focused blood marker levels during the treatment and post treatment phases: (High sensitivity C-reactive protein (hs-CRP); Erythrocyte Sedimentation Rate (ESR); Interleukin-6 (IL-6); Tumor Necrosis Factor (TNF) )
Crystal Lederhos Smith
Other
Safety and Behavioral Pharmacology of Cannabichromene as an Adjunct to Rheumatoid Arthritis Treatment; Effects on Inflammatory Markers and Rheumatoid Arthritis Disease Activity
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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