MC-RWE : Real World Evidence in Patient-Reported Outcomes for Medical Cannabis: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change in pain intensity from baseline to week 24 post-authorization of MC: Measured using the numerical rating scale (NRS).
研究概览
简要总结
This prospective observational study aims to describe the effectiveness of MC on pain, epilepsy, sleep and /or anxiety/depression in a cohorts of patients authorized to use MC, using pre-defined, validated self assessment scales.
详细描述
Given the recent legislative changes, medical cannabis has quickly garnered attention in clinical research as a potential pharmacotherapy to treat epilepsy, mood disorders, anxiety/depression disorders, sleep disorders and pain (neuropathic and non-cancer chronic pain)-conditions with often debilitating patient impact, substantive economic burden, and limited treatment options.
While there is growing evidence that MC may be an effective therapeutic option for patients suffering from chronic medical conditions, clinical research on medical cannabis has focused primarily on short-term outcomes, with limited attention to long-term benefits of specific strains, dosing regimens or treatment modalities. In addition, patients using MC generally are unable to maintain a defined treatment regimen (whether defined by strain name, biochemical composition, or mode of ingestion) over a long period of time. Even for patients desiring to maintain treatment with the same regimen, it may be impossible to do so, given the tendency for recreational and licensed medical producers to change their strains and product line up without notice. Such changes complicate MC users' efforts to optimize their overall health outcomes, as well as researchers' ability to study long-term effectiveness and safety of MC in general, and specific strains in particular.
Over the last few years, there has been an influx of new growers and an introduction of many new cannabis strains, each with a different representation of at least 500 known metabolites. Subtle changes in strain composition may have significant clinical effects. With so many strains available, and with limited information on strain composition and genetics, patients have little ability to control what they are taking over time.
The current real-world study addresses these complexities by providing patients verified MC strains and products, allowing them to maintain their treatment if desired or alter its composition in order to identify dosing regimens that work for them.
This study will provide much-needed pragmatic and objective information for patients and their clinicians about the effectiveness of verified MC products in the real-world setting using validated patient report outcome (PRO) tools.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects (≥19 years of age) who are MC-naïve or -experienced with a medical authorization for MC provided by a prescribing health care practitioner and who have provided informed consent
- •Primary therapeutic indications for MC use: pain, epilepsy, sleep, and/or anxiety/depression.
- •Subjects agree to use verified products and refrain from using any other cannabis products, either medical or recreational, during the duration of the study
排除标准
- •Concomitant use of illicit drugs
- •Concomitant use of recreational cannabis
结局指标
主要结局
Change in pain intensity from baseline to week 24 post-authorization of MC: Measured using the numerical rating scale (NRS).
时间窗: Baseline, 6, 12, 18 (if applicable) and 24 weeks
The 11-point NRS ranges from '0' being no pain to '10'' being the worst pain imaginable. Higher pain scores indicate greater pain intensity.
Change in pain interference from baseline to week 24 post-authorization of MC: Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference short form 6a.
时间窗: Baseline, 6, 12, 18 (if applicable) and 24 weeks
The PROMIS-short form 6a measures six items on 5-point scales (1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit and 5=very much) for pain interference on aspects of daily life. Scores are calculated from the total of item responses, with higher scores reflecting greater pain interference.
Sleep: Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to week 24 post-authorization of MC
时间窗: Baseline, 6, 12, 18 (if applicable) and 24 weeks
The PSQI contains 19-self rated questions and 5-questions rated by the roommate or bed partner. The 19 self-rated questions are combined to form seven component scores, each of which has a range of 0-3 points (0=no difficulty to 3=severe difficulty). Higher scores indicate worse sleep quality.
Anxiety: Change in the symptoms from baseline to week 24 post-authorization of MC; Measured using Generalized Anxiety Disorder 7-item scale (GAD-7).
时间窗: Baseline, 6, 12, 18 (if applicable) and 24 weeks
This 7-item scale assesses the signs of GAD (e.g. ''Feeling afraid as if something awful might happen") with response option of : 0= Not at all, 1=Several days, 2= More than half the days and 3= Nearly everyday. Scores are calculated from the total of item responses, with higher scores reflecting greater anxiety.
Depression: Change in the symptoms from baseline to week 24 post-authorization of MC. Measured by Patient Health Questionnaire 9 item scale (PHQ-9).
时间窗: Baseline, 6, 12, 18 (if applicable) and 24 weeks
The PHQ-9 assesses the signs of depression (e.g. Little interest or pleasure in doing things) with response option of : 0= Not at all, 1= Several days, 2= More than half the days, 3= Nearly everyday. Scores are calculated from the total of item responses, with higher scores reflecting the severity of depression.
Change in quality of life from baseline to Week 24: Measured using EuroQuol-5D-3-level health questionnaires(EQ-5D-3L) assessment scale.
时间窗: Baseline, 6, 12, 18 (if applicable) and 24 weeks
The EQ-5D-3L assesses health state in each of 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) on 3-point scale (no problems, some problems, extreme problems). Patients also rate their health on a vertical visual analogue scale with the endpoints "The best health you can imagine" and "The worse health you can imagine".
Epilepsy: change in seizure frequency for multiple different seizure types from baseline to Week 24
时间窗: Baseline, 6, 12, 18 and 24 weeks
Seizure frequency will be documented in a patient diary, and number of seizures of each seizure type in the preceding 6 weeks will be reported.
次要结局
- Demographics(Baseline)
- Clinical characteristics of patients(Baseline)
- Patient satisfaction with the e-commerce platform's support team(24 weeks after study initiation)
- Changes in prescription medications of interest(24 weeks after study initiation)
研究者
Jo Carroll
Research Manager
University Health Network, Toronto