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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis

Intervention / Treatment
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* Drug: Cannabis: placebo and medium THC/medium CBD


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vaporized cannabis: placebo<br>Vaporized cannabis: placebo dose | Drug: Cannabis: placebo and medium THC/medium CBD<br>* Vaporized cannabis: placebo and medium THC/medium CBD<br>* Other names: Marijuana;|
| Experimental: Vaporized cannabis: medium THC/medium CBD<br>Vaporized cannabis: medium THC/medium CBD dose | Drug: Cannabis: placebo and medium THC/medium CBD<br>* Vaporized cannabis: placebo and medium THC/medium CBD<br>* Other names: Marijuana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective pain level | short-form McGill Pain Questionnaire (SF-MPQ) | pre-cannabis administration, at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration), and 60 minutes post-completion of cannabis administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported affect | Positive and Negative Affect Scale (PANAS) | pre-cannabis administration, at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration), and 60 minutes post-completion of cannabis administration | 
| Change in level of Inflammatory biomarkers | Interleukin 6 (IL-6) and Tumor necrosis factor alpha (TNF-α) | pre-cannabis administration, at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration), and 60 minutes post-completion of cannabis administration |