Reducing Severe Breathlessness With Dronabinol in Severe and Very Severe COPD Patients A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

What this Trial Is About

Researchers are evaluating whether Dronabinol, a drug containing the synthetic compound tetrahydrocannabinol (THC), can reduce severe breathlessness in adults with severe and very severe chronic obstructive pulmonary disease (COPD). This randomized, controlled, double-blind crossover study compares Dronabinol with a placebo to assess its effects on breathlessness in these patients. Participants will receive treatment in two phases: one with Dronabinol capsules and one with matching placebo capsules. Each treatment phase lasts four weeks, including two weeks of dose titration up to 20 mg daily divided into three doses, followed by two weeks of steady dosing. A two-week washout period separates the two treatment phases. The order of treatments is randomized, so each participant receives both Dronabinol and placebo in a different sequence. During the study, participants will attend eight visits, including enrollment and follow-ups every two weeks. They will complete questionnaires about breathlessness and overall health, undergo lung function tests and six-minute walk tests, and provide blood samples to measure THC levels and hair samples for cortisol analysis. Daily breathlessness ratings and health data will be collected using questionnaires and a wearable watch. The study aims to measure differences in breathlessness discomfort and interference with activities between Dronabinol and placebo treatments over up to 70 days.

Reducing Breathlessness With Dronabinol in COPD Patients