Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis

Last updated: March 14, 2025
Sponsor: Brown University
Overall Status: Terminated

Phase

2

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Treatment

Cannabis: placebo and medium THC/medium CBD

Clinical Study ID

NCT04269993
#1904002430
P20GM130414
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This laboratory study will investigate the impact of cannabis on pain, affect, and inflammation among patients with rheumatoid or psoriatic arthritis (n = 76). Two cannabis formulations varying in potency will be administered via vaporization across two experimental sessions using a counter-balanced, double-blind, crossover design.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. current RA or PA diagnosis with active arthritis not adequately controlled bystandard medication

  2. if taking prescribed steroid, non-steroidal anti-inflammatory (NSAID), and/ordisease-modifying anti-rheumatic drug (DMARDS; e.g., tumor necrosis factorinhibitors), must be stable use for at least 1 month prior to enrollment (all mustbe maintained throughout the study)

  3. English-speaking or Spanish-speaking

  4. negative urine toxicology screen

  5. negative pregnancy test

  6. not nursing

  7. use of highly effective birth control during the study for both males and females

  8. prior history of vaping or smoking cannabis

Exclusion

Exclusion Criteria:

  1. greater than zero breath alcohol concentration

  2. presence of psychosis, panic disorder, or suicidal ideation or intent

  3. self-report of serious adverse reaction to cannabis in the past year

  4. smoking more than 20 tobacco cigarettes per day

  5. body mass index below 18.0 or above 33.0 kg/m2 range confirmed during medical exam

  6. all current asthma conditions (i.e., active symptomatic asthma within the last week)or current or past history of asthma triggered by smoking or vaping

  7. current diagnosis of dementia or Parkinson's disease

  8. below cut-off on mental status exam

  9. current diagnosis of moderate to severe traumatic brain injury

  10. current diagnosis of epilepsy

  11. individuals who are immunocompromised (i.e., post-organ transplant, those with animmune deficiency disorder such as HIV, individuals taking immunosuppressantsteroids such as continuous prednisone use, and those with lupus)

  12. past kidney disease (e.g., glomerular nephritis, polycystic kidney disease) and/orpresence of elevated creatinine

  13. cardiac disease confirmed via clinically significant abnormal findings on an EKG (e.g., arrhythmia, conduction abnormalities, ischemia, or evidence of pastmyocardial infarction), as well as diagnoses of congestive heart failure orcardiomyopathy

  14. abnormal vital signs

  15. taking any exclusionary medications

  16. presence of any severe cardiovascular, renal, or hepatic disorder

  17. below 18 or above 65 years of age

  18. use of cannabis in the past 1 month before commencement of study participation andthroughout the study as confirmed via urine toxicology screening aa) below minimumself-reported pain level on a visual analog scale (VAS) pre-study enrollment viatelephone and at baseline due to potential variability in pain level

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: Cannabis: placebo and medium THC/medium CBD
Phase: 2
Study Start date:
May 18, 2022
Estimated Completion Date:
July 31, 2023

Study Description

This laboratory study will investigate the impact of cannabis on pain, affect, and inflammation among patients with rheumatoid or psoriatic arthritis (n = 76). Two cannabis formulations varying in potency will be administered via vaporization across two experimental sessions using a counter-balanced, double-blind, crossover design. Blood will be collected during each session (pre-vaporization, 10 minutes post-vaporization, 60 minutes post-vaporization). Self-reported pain and affect will be assessed at the same time points. The effect of cannabis on pain, affect, and inflammatory biomarkers will be assessed. The study will recruit 76 patients to obtain a final sample of 66 with complete data (15% attrition). This study will be the first to investigate the effect of cannabis on pain, affect, and markers of inflammation among patients with rheumatoid or psoriatic arthritis. This study has the potential to guide clinical decisions pertaining to use of cannabis to treat arthritis symptoms with more precise recommendations regarding cannabis formulation.

Connect with a study center

  • Brown University School of Public Health

    Providence, Rhode Island 02903
    United States

    Site Not Available

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