Verified February 2017 by McGill University
Sponsor:
Information provided by (Responsible Party):
Dennis Jensen, Ph.D., McGill University
ClinicalTrials.gov Identifier:
NCT03060993
First received: February 11, 2017
Last updated: February 18, 2017
Last verified: February 2017
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.
| Chronic Obstructive Pulmonary Disease (COPD) Breathlessness Exercise Intolerance |
Drug: Cannabis Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Effect of Inhaled Vaporized Cannabis on Pulmonary Function, Breathlessness and Exercise Tolerance in Symptomatic Patients With Advanced Chronic Obstructive Pulmonary Disease (COPD) |
- Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing. [ Time Frame: 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. [ Time Frame: 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 Spirometry [ Time Frame: 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
- Changes in Impulse oscillometry [ Time Frame: 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. [ Time Frame: 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.
- Plasma cannabinoid levels. [ Time Frame: 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
- Psychoactive effects. [ Time Frame: 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.
- Mood effects. [ Time Frame: 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.
- Cognitive effects. [ Time Frame: 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
| Estimated Enrollment: | 16 |
| Anticipated Study Start Date: | March 1, 2017 |
| Estimated Study Completion Date: | April 30, 2018 |
| Estimated Primary Completion Date: | January 1, 2018 (Final data collection date for primary outcome measure) |
| Placebo Comparator: 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. |
Drug: Placebo
Patients will be administered placebo (cannabis stripped of cannabinoids) in vaporized form. |
| Active Comparator: 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. |
Drug: Cannabis
Patients will be administered cannabis (THC/CBD) in vaporized form. |
| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03060993
| Contact: Sara Abdallah, MSc. | 514-934-1934 ext 32465 |
| McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre | |
| Montreal, Quebec, Canada, H4A 3J1 | |
| Contact: Sara Abdallah, MSc. 514-934-1934 ext 32465 | |
| Principal Investigator: Dennis Jensen, Ph.D. | |
| Sub-Investigator: Jean Bourbeau, M.D. | |
| Sub-Investigator: Benjamin Smith, M.D. | |
| Sub-Investigator: Mark Ware, M.D. | |
McGill University
| Principal Investigator: | Dennis Jensen, Ph.D. | McGill University |
| Responsible Party: | Dennis Jensen, Ph.D., Assistant Professor, McGill University |
| ClinicalTrials.gov Identifier: | NCT03060993 History of Changes |
| Other Study ID Numbers: | CNBS001 |
| Study First Received: | February 11, 2017 |
| Last Updated: | February 18, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by McGill University:
| Cannabis Marijuana |
Additional relevant MeSH terms:
| Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Dyspnea |
Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on February 23, 2017