Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis (NCT04269993) | Clinical Trial Compass
TerminatedPhase 2
Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis
Stopped: Termination of study funding
United States3 participantsStarted 2022-05-18
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. greater than zero breath alcohol concentration
✕0. presence of psychosis, panic disorder, or suicidal ideation or intent
What they're measuring
1
Subjective Pain Level Post-vaporization
Timeframe: at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration)
✕1. self-report of serious adverse reaction to cannabis in the past year
✕2. smoking more than 20 tobacco cigarettes per day
✕3. body mass index below 18.0 or above 33.0 kg/m2 range confirmed during medical exam
✕4. 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
✕5. current diagnosis of dementia or Parkinson's disease