What question did this study set out to answer?

The study aims to determine if dronabinol reduces breathlessness in patients with severe chronic obstructive pulmonary disease when compared to placebo.

February 19, 2026BMJ Open0 citationsOpen Access

Reducing severe breathlessness with dronabinol in the group of patients with severe and very severe chronic obstructive pulmonary disease (BONG): a randomised, double-blinded, placebo-controlled, crossover study in an outpatient clinic in Denmark – a study protocol

SWSofie Krogh WolsingUniversity of Southern Denmark OHOle HilbergUniversity of Southern Denmark ALAnders LøkkeUniversity of Southern Denmark

Key Points

The study aims to determine if dronabinol reduces breathlessness in patients with severe chronic obstructive pulmonary disease when compared to placebo.
Single-centre, randomised, double-blinded, placebo-controlled, crossover trial
Enrolment of 30 patients with severe COPD experiencing persistent breathlessness
Treatment with dronabinol or placebo for 4 weeks, followed by a 2-week washout period before switching treatments
Monitoring of various health parameters, including lung function and cortisol levels
Primary outcome is measured using a 0–10 Numerical Rating Scale for breathing discomfort
Secondary outcomes include lung function tests and various quality of life questionnaires
Continuous monitoring of vital signs and activity through wearable technology

Abstract

Introduction Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of Δ 9 -tetrahydrocannabinol (Δ 9 -THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo. Methods This single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged ≥18 years) will receive either dronabinol or placebo for 4 weeks, followed by a 2-week washout, before crossing over to the other treatment for 4 weeks. Exclusion criteria include ongoing infection, substance abuse and significant comorbidities. Primary outcome is breathing discomfort or unpleasantness measured using the 0–10 Numerical Rating Scale. Secondary outcomes include lung function (forced expiratory volume in one second), hair cortisol concentrations, functional tests, plasma THC blood concentrations and questionnaires assessing breathlessness, activity, quality of life, anxiety and depression. Continuous monitoring of vital signs, activity and sleep will be performed using a Garmin Venu 3 smartwatch. Data will be entered into electronic case report forms and monitored by the Good Clinical Practice (GCP) unit in Odense. Discussion This will be the largest randomised, double-blinded, crossover trial to investigate dronabinol in patients with COPD and will provide new knowledge on the efficacy and safety. Ethics and dissemination Written informed consents will be obtained from study patients. The study has been approved by the Danish Medicines Agency (case number: 2023010659) and the medical research ethics committees (case number: 2301456). It is registered in the European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov ( NCT06473701 ). The trial follows the Declaration of Helsinki II and International Council for Harmonisation-GCP guidelines. Findings will be disseminated in peer-reviewed publications. Trial registration number The European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov ( NCT06473701 ).

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