Effect of Inhaled Vaporized Cannabis on Pulmonary Function, Breathlessness and Exercise Tolerance in Symptomatic Patients With Advanced Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Changes in cycle exercise endurance time.
研究概览
简要总结
A growing body of physiological evidence now exists to support a potential role for inhaled cannabis in the medical management of adults with chronic obstructive pulmonary disease (COPD), particularly as it may related to improving pulmonary function, alleviating the symptom of breathlessness and improving exercise endurance. The purpose of this randomized double-blind crossover trials is to evaluate the efficacy and physiological mechanism(s) of action of inhaled vaporized cannabis targeted to relief of physical activity-related breathlessness and exercise endurance in symptomatic patients with severe-to-very severe COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GOLD stage III or IV COPD (i.e., post-β2-agonist FEV1 of 50% predicted or less)
- •Self-reported cigarette smoking history ≥10 pack yrs
- •Currently taking long-acting beta-2 agonists and long-acting antimuscarinic agents (LABA/LAMAs) with or without an inhaled corticosteroid
- •Willing to abstain from cannabis smoking for ≥15 days prior to study participation (if applicable)
- •Willing to abstain from non-study related cannabis smoking throughout the study period (if applicable)
- •No change in medication dosage or frequency of administration, with no exacerbations or hospitalizations in the preceding 4 weeks
排除标准
- •Presence of active and/or uncontrolled cardiopulmonary and/or musculoskeletal disease other than COPD that could contribute to breathlessness and exercise intolerance
- •Hepatic or renal impairment
- •Psychiatric history (other than depression and/or anxiety)
- •History of epilepsy or convulsions;
- •Lung cancer
- •History of sensitivity to cannabis
- •Use of levodopa, sildenafil and/or fentanyl
- •Use of ketoconazole
- •Use of regular high dose opioids (i.e., 30 mg of oral morphine equivalents/day)
- •Known or suspected history of addiction/substance abuse based on CAGE-AID and SISAP scores (*note, patients may be recruited if they have a history of smoking cannabis)
- •Positive urine toxicology for cannabinoids on screening
- •Positive pregnancy urine test
- •Subject cannot arrange to be accompanied home by a family member and/or friend during each treatment visit.
研究组 & 干预措施
Placebo
35 mg of tetrahydrocannabinol/cannabidiol (LT1.0/LT1.0 %) in vaporized form. Placebo will be vaporized using the Volcano Medic vaporizer. Total volume of vapour administered to each patient will be 5.5 L.
干预措施: Placebo (Drug)
Cannabis
35 mg of cannabis (tetrahydrocannabinol/cannabidiol; 18.0/LT1.0 %) in vaporized form. THC/CBD will be vaporized using the Volcano Medic vaporizer. Total volume of vapour administered to each patient will be 5.5 L.
干预措施: Cannabis (Drug)
结局指标
主要结局
Changes in cycle exercise endurance time.
时间窗: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Exercise endurance time will be defined as the duration of loaded pedaling during the constant-load cycle exercise testing performed at 75% of peak incremental power output.
Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing.
时间窗: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Patients will be required to rate the intensity of their breathlessness using Borg's modified 0-10 category ratio scale every 2-minutes during cycle exercise testing.
次要结局
- Changes in Spirometry(Participants will be followed until all study visits are complete, an expected average of 4 weeks)
- Changes in Physiological responses during exercise.(Participants will be followed until all study visits are complete, an expected average of 4 weeks)
- Mood effects.(Participants will be followed until all study visits are complete, an expected average of 4 weeks)
- Changes in Impulse oscillometry(Participants will be followed until all study visits are complete, an expected average of 4 weeks)
- Psychoactive effects.(Participants will be followed until all study visits are complete, an expected average of 4 weeks)
- Cognitive effects.(Participants will be followed until all study visits are complete, an expected average of 4 weeks)
- Plasma cannabinoid levels.(Participants will be followed until all study visits are complete, an expected average of 4 weeks)
研究者
Dennis Jensen, Ph.D.
Assistant Professor
McGill University