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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. current RA or PA diagnosis with active arthritis not adequately controlled by standard medication. 2. if taking prescribed steroid, non-steroidal anti-inflammatory (NSAID), and/or disease-modifying anti-rheumatic drug (DMARDS; e.g., tumor necrosis factor inhibitors), must be stable use for at least 1 month prior to enrollment (all must be 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 Criteria:

9. greater than zero breath alcohol concentration. 10. presence of psychosis, panic disorder, or suicidal ideation or intent. 11. self-report of serious adverse reaction to cannabis in the past year. 12. smoking more than 20 tobacco cigarettes per day. 13. body mass index below 18.0 or above 33.0 kg/m2 range confirmed during medical exam. 14. 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. 15. current diagnosis of dementia or Parkinson's disease. 16. below cut-off on mental status exam. 17. current diagnosis of moderate to severe traumatic brain injury. 18. current diagnosis of epilepsy. 19. individuals who are immunocompromised (i.e., post-organ transplant, those with an immune deficiency disorder such as HIV, individuals taking immunosuppressant steroids such as continuous prednisone use, and those with lupus) 20. past kidney disease (e.g., glomerular nephritis, polycystic kidney disease) and/or presence of elevated creatinine. 21. cardiac disease confirmed via clinically significant abnormal findings on an EKG (e.g., arrhythmia, conduction abnormalities, ischemia, or evidence of past myocardial infarction), as well as diagnoses of congestive heart failure or cardiomyopathy. 22. abnormal vital signs. 23. taking any exclusionary medications. 24. presence of any severe cardiovascular, renal, or hepatic disorder. 25. below 18 or above 65 years of age. 26. use of cannabis in the past 1 month before commencement of study participation and throughout the study as confirmed via urine toxicology screening aa) below minimum self-reported pain level on a visual analog scale (VAS) pre-study enrollment via telephone and at baseline due to potential variability in pain level

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04269993
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Brown University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Elizabeth Aston, PhD
Principal Investigator Affiliation Brown University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

Placebo Comparator: Vaporized cannabis: placebo

Vaporized cannabis: placebo dose

Experimental: Vaporized cannabis: medium THC/medium CBD

Vaporized cannabis: medium THC/medium CBD dose

Interventions

Drug: - Cannabis: placebo and medium THC/medium CBD

Vaporized cannabis: placebo and medium THC/medium CBD

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brown University School of Public Health, Providence, Rhode Island

Status

Recruiting

Address

Brown University School of Public Health

Providence, Rhode Island, 02903

Site Contact

Elizabeth Aston, PhD

elizabeth_aston@brown.edu

401-863-6668

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.