Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT03060993
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03060993
Study Brief:
Protocol Section:
NCT03060993