NCT07087938

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
23mo left

Started Jul 2028

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2024

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
3 years until next milestone

Study Start

First participant enrolled

July 15, 2028

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

July 28, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

May 31, 2024

Last Update Submit

July 23, 2025

Conditions

Arthritis, Rheumatoid

Keywords

CannabichromeneCBCHCBCMinor cannabinoidCBC in humansRheumatoid ArthritisSafety

Outcome Measures

Primary Outcomes (5)

  • Incidence of Observed Adverse Events

    Observed Adverse events

    20 Weeks

  • Incidence of Serious Adverse Events

    Observed Serious adverse events

    20 Weeks

  • Incidence of Side-Effects Reported by Participants

    Participant self-report of side-effects

    20 Weeks

  • 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.

    20 Weeks

  • 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.

    20 Weeks

Secondary Outcomes (2)

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

    20 Weeks

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

    20 Weeks

Study Arms (2)

Study Group 1

ACTIVE COMPARATOR

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.

Drug: Cannabichromene

Study Group 2

ACTIVE COMPARATOR

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.

Drug: Cannabichromene

Interventions

CannabichromeneDRUG

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.

Also known as: CAS Number: 20675-51-8, CBC, NSC 291831
Study Group 1Study Group 2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

cannabichromene

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Crystal L Smith, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to dose but will know they are all getting active product.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to begin with one of two study doses (400mg or 600mg daily) using a block randomization schedule.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 31, 2024

First Posted

July 28, 2025

Study Start (Estimated)

July 15, 2028

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

May 31, 2030

Last Updated

July 28, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)