AzTrials
AzTrials

Arthritis, RheumatoidPhase 1/2NCT07087938

Cannabichromene Safety in Rheumatoid Arthritis

A Phase 1/2 study testing Cannabichromene in people with Arthritis, Rheumatoid, run by Crystal Lederhos Smith at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Cannabichromene
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Jul 2028to 31 May 2030
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Washington State University

    Spokane, Washington, 99202

Other trials in United States

About this study

Official title: Safety and Behavioral Pharmacology of Cannabichromene as an Adjunct to Rheumatoid Arthritis Treatment; Effects on Inflammatory Markers and Rheumatoid Arthritis Disease Activity

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.

Read the detailed 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.

Being tested
Cannabichromene
Keywords
Cannabichromene, CBCH, CBC, Minor cannabinoid, CBC in humans, Rheumatoid Arthritis, Safety
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabichromeneDrug

    Also called CAS Number: 20675-51-8, CBC, NSC 291831

    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.

Study groups in NCT07087938
Study groupRoleWhat they receive
Study Group 1Active comparatorParticipants 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.
Receives: Drug: Cannabichromene
Study Group 2Active comparatorParticipants 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.
Receives: Drug: Cannabichromene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Observed Adverse Events

    Observed Adverse events

    Measured: 20 Weeks

  2. Incidence of Serious Adverse Events

    Observed Serious adverse events

    Measured: 20 Weeks

  3. Incidence of Side-Effects Reported by Participants

    Participant self-report of side-effects

    Measured: 20 Weeks

  4. Description of Safety Focused Blood Markers (CMP)

    Safety focused blood marker levels aggregated through Comprehensive Metabolic Panel (CMP) during the treatment and post treatment phases.

    Measured: 20 Weeks

  5. Description of Safety Focused Blood Markers (CBC)

    Safety focused blood marker levels aggregated through Complete Blood Count (CBC) during the treatment and post treatment phases.

    Measured: 20 Weeks

Secondary outcomes (2)

  1. Number of Participants With CBC Treatment-Related Reduction of RA Disease Activity as Assessed by DAS28.

    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.

    Measured: 20 Weeks

  2. Number of Participants With CBC Treatment-Related Reduced Inflammatory Blood Markers as Assessed by hs-CRP, ESR, IL-6, and TNF Tests.

    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) )

    Measured: 20 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2025
  2. Study start15 Jul 2028 (estimated)
  3. Primary completion31 May 2030 (estimated)
  4. Study completion31 May 2030 (estimated)

Why it stopped: Study did not begin recruiting participants due to insufficient preclinical evidence resulting in FDA clinical hold.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to begin with one of two study doses (400mg or 600mg daily) using a block randomization schedule.
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07087938
Sponsor's protocol ID
20353-001
Status last verified
Aug 2026
First submitted
31 May 2024
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Deidentified and summarized participant data will be available to other researchers upon request. No IPD will be available due to the focused recruitment strategy, in an effort to provide protection to participants identities.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cannabichromene in people with Arthritis, Rheumatoid, run by Crystal Lederhos Smith at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Observed Adverse Events (time frame: 20 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07087938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in