Short summary

This is a randomized, controlled, double blinded, crossover trial testing the pharmaceutical drug Dronabinol for patients with severe and very severe chronic obstructive pulmonary disease. We vill investigate whether Dronabinol, containing the psychoactive compound tetrahydrocannabinol from synthetic produced cannabis, alleviates breathlessness. We will recruit 30 patients with severe and very severe COPD from the pulmonary outclinic at Vejle Hospital. Each subject will participate in 3 months.

Rationale

Chronic obstructive pulmonary disease (COPD) can lead to debilitating breathlessness where conventional treatments like inhalation drugs or even morphine is insufficient. However, preliminary research suggests potential effects of tetrahydrocannabinol (THC) in the lung tissue and in the area of the brain connected to perception of breathlessness. Therefore, this randomized, double-blinded, crossover trial in patients with severe COPD, aims to assess whether Dronabinol, a form of THC, reduces severe breathlessness as compared to placebo. Hypotheses: 1) Subjects will report lower breathlessness intensity during Dronabinol treatment versus placebo treatment, assessed by using a numeric rating scale (NRS) 2) Higher blood cannabinoid concentrations will correlate with lower NRS scores

Description of the cohort

Patients with severe and very severe COPD who have an outpatient course at the Pulmonary Outpatient Clinic, Vejle Hospital will be invited to participate in the trial if they meet the inclusion and exclusion criteria.

Data and biological material

- Clinical examinations - Patient reported information (side effects, medication compliance, questionnaires) - Biological material (blood tests, urine samples, hair samples) - Physical tests (6MWT, spirometry, data from Empatica Embrace watch) - Subject information (demographic, diagnosis etc.)

Collaborating researchers and departments

Biochemistry and Immunology, Vejle Hospital

• Claus Brasen
• Anne Katrine Wolf Schmidt-Hansen

Department of Forensic Medicine, Division of Forensic Chemistry, Aarhus University

• Charlotte Uggerhøj Andersen

Glostrup Pharmacy

• Kristian Østergaard

Hospital Pharmacy, Vejle Hospital

• Majken Cardel