Breathlessness, Chronic Obstructive Pulmonary Disease (COPD), Exercise Intolerance
Conditions
Keywords
Cannabis, Marijuana
Brief summary
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.
Interventions
DRUGCannabis
Patients will be administered cannabis (THC/CBD) in vaporized form.
DRUGPlacebo
Patients will be administered placebo (cannabis stripped of cannabinoids) in vaporized form.
Sponsors
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing. | 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. |
| Changes in cycle exercise endurance time. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Impulse oscillometry | Participants will be followed until all study visits are complete, an expected average of 4 weeks | Impulse oscillometry will be performed before and 10-min after treatment administration |
| Changes in Physiological responses during exercise. | Participants will be followed until all study visits are complete, an expected average of 4 weeks | Gas exchange, cardiovascular and breathing pattern variables will be collected breath-by-breath and averaged in 30-sec epochs during incremental and constant-load cycle exercise tests. |
| Mood effects. | Participants will be followed until all study visits are complete, an expected average of 4 weeks | Mood effects of cannabis will be evaluated during each treatment visit using 100-mm visual analogue scale (VAS). Mood effects will be evaluated before and 45-min after treatment administration. |
| Psychoactive effects. | Participants will be followed until all study visits are complete, an expected average of 4 weeks | Psychoactive effects of cannabis will be evaluated during each treatment visit using 100-mm visual analogue scale (VAS). Psychoactive effects will be evaluated before and 45-min after treatment administration. |
| Cognitive effects. | Participants will be followed until all study visits are complete, an expected average of 4 weeks | Cognitive effects will be measured during each treatment visit using the mini-mental state exam. The mini-mental state exam will be administered before and 45-min after treatment administration |
| Plasma cannabinoid levels. | Participants will be followed until all study visits are complete, an expected average of 4 weeks | Venous blood samples for the determination of circulating levels of cannabinoids will be collected before and 2-, 30-, 75-, and 180-min after vaporization |
| Changes in Spirometry | Participants will be followed until all study visits are complete, an expected average of 4 weeks | Spirometry will be performed before and 5-min after treatment administration |
Countries
Canada
Contacts
Primary ContactSara Abdallah, MSc.
Outcome results
None listed