Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Subjective Pain Level Post-vaporization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Subjective Pain Level Post-vaporization
时间窗: 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
次要结局
未报告次要终点
研究者
Elizabeth Aston
Assistant Professor
Brown University