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

Phase 2

Terminated

Conditions: Rheumatoid Arthritis
Psoriatic Arthritis

Registration Number: NCT04269993

Lead Sponsor: Brown University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures