Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGCannabis: placebo and medium THC/medium CBD
Vaporized cannabis was administered to participants (placebo and medium THC/medium CBD).
Sponsors
National Institute of General Medical Sciences (NIGMS)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Pain Level Post-vaporization | at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration) | Short-Form McGill Pain Questionnaire (SF-MPQ) Scale range to describe current pain level: 0 'none' to 10 'worst possible' \*higher scores indicate more severe pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaporized Cannabis: Placebo Then Active THC Participants are randomized to receive placebo cannabis during Session 1 and Active THC cannabis during Session 2; sessions will be separated by at least 2 days | 1 |
| Vaporized Cannabis: Active THC Then Placebo Participants are randomized to receive Active THC cannabis during Session 1 and placebo cannabis during Session 2; sessions will be separated by at least 2 days | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Vaporized Cannabis: Placebo Then Active THC | Total | Vaporized Cannabis: Active THC Then Placebo |
|---|---|---|---|
| Age, Continuous | 23 years | 45.67 years STANDARD_DEVIATION 19.66 | 57 years STANDARD_DEVIATION 1.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Subjective Pain Level Post-vaporization
Short-Form McGill Pain Questionnaire (SF-MPQ) Scale range to describe current pain level: 0 'none' to 10 'worst possible' \*higher scores indicate more severe pain
Time frame: at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaporized Cannabis: Placebo Then Active THC | Subjective Pain Level Post-vaporization | Placebo Dose | 3 score on a scale | — |
| Vaporized Cannabis: Placebo Then Active THC | Subjective Pain Level Post-vaporization | Medium THC/Medium CBD Dose | 4 score on a scale | — |
| Vaporized Cannabis: Active THC Then Placebo | Subjective Pain Level Post-vaporization | Placebo Dose | 2 score on a scale | Standard Deviation 1.414 |
| Vaporized Cannabis: Active THC Then Placebo | Subjective Pain Level Post-vaporization | Medium THC/Medium CBD Dose | 4.5 score on a scale | Standard Deviation 2.121 |
p-value: 0.04t-test, 1 sided