Cannabichromene Safety in Rheumatoid Arthritis

Crystal Lederhos Smith

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Cannabichromene

Study type: Interventional

Funder types: Other

Identifiers

NCT07087938

20353-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a current diagnosis of RA
• Having stable treatment for at least 1 month prior to the study and being willing to continue that treatment for the duration of the study
• Having some degree of disease activity present at research study intake (determined by research study personnel)
• Aged 21+
• Able to read and speak English, and provide written consent
• Not currently pregnant or planning to become pregnant during the trial
• Not currently planning any surgeries during the course of the trial
• Willing to use a form of birth control for the duration of the study (all participants will be required to use birth control for the duration of the study)
• Willing to refrain from cannabis use (other than study provided CBC) over the course of the study

Exclusion criteria

• Do not have a current diagnosis of RA
• Has not received stable treatment for at least 1 month prior to the study or is unwilling to continue treatment for the duration of the study
• No degree of disease activity present at research study intake (determined by research study personnel)
• Under age 21
• Unable to read and speak English, or provide written consent
• Are currently pregnant or planning to become pregnant during the course of the trial
• Unwilling to use a form of birth control during the duration of the study
• Is planning a surgery during the course of their participation in the trial
• Unwilling to refrain from cannabis use (other than study provided CBC) over the course of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Study Group 1

Active Comparator group

Description:

Participants will be administered dose one (400mg CBC daily) for eight weeks, and at visit three they will receive dose two (600mg CBC daily) and will take it for eight weeks, concluding the study with another two-week washout period.

Treatment:

Drug: Cannabichromene

Study Group 2

Active Comparator group

Description:

Participants will be administered dose one (600mg CBC daily) for eight weeks, and at visit three they will receive dose two (400mg CBC daily) and will take it for eight weeks, concluding the study with another two-week washout period.

Treatment:

Drug: Cannabichromene