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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis, Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT04269993

Run by

Brown University

People needed

3

Starts

2022-05-18

Expected to finish

2023-07-31

Last updated by the study team

2025-04-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• current RA or PA diagnosis with active arthritis not adequately controlled by standard medication
• 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)
• English-speaking or Spanish-speaking
• negative urine toxicology screen
• negative pregnancy test
• not nursing
• use of highly effective birth control during the study for both males and females
• prior history of vaping or smoking cannabis

You may not qualify if…

• greater than zero breath alcohol concentration
• presence of psychosis, panic disorder, or suicidal ideation or intent
• self-report of serious adverse reaction to cannabis in the past year
• smoking more than 20 tobacco cigarettes per day
• body mass index below 18.0 or above 33.0 kg/m2 range confirmed during medical exam
• 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
• current diagnosis of dementia or Parkinson's disease
• below cut-off on mental status exam
• current diagnosis of moderate to severe traumatic brain injury
• current diagnosis of epilepsy
• 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)
• past kidney disease (e.g., glomerular nephritis, polycystic kidney disease) and/or presence of elevated creatinine
• 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
• abnormal vital signs
• taking any exclusionary medications
• presence of any severe cardiovascular, renal, or hepatic disorder
• below 18 or above 65 years of age
• 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

Where it is running

• Brown University School of Public Health — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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