NCT06473701CompletedPhase 3
Reducing Breathlessness With Dronabinol in COPD Patients
BONG: Reducing Severe Breathlessness With Dronabinol in the Severe and Very Severe Chronic Obstructive Pulmonary Disease Patient Group - A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
This clinical trial examines whether Dronabinol, which contains the synthetic psychoactive compound tetrahydrocannabinol (THC), can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 22 May 2024
- Start date
- 26 Feb 2025
- Primary completion date
- 21 Sept 2026
- Lead sponsor
- Vejle Hospital
- Diseases
- COPD
- NCT number
- NCT06473701
- EU CT number
- 2024-513593-22-00
- EudraCT number
- 2022-004238-20
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 30
- From 26 Feb 2025 to the primary completion date, 21 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular treatment with THC or CBD within 1 month (30 days)
- Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19
Other illness
- Ongoing infection or exacerbation of COPD within the last month (30 days)
- History of or current evidence of significant medical or psychiatric disorder that is considered by the investigator to put the subject at greater risk of experiencing an adverse event
Other
- Life expectancy less than 3 months (90 days)
- Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study
Who the study is looking for
- Refractory dyspnea despite optimal treatment
- COPD (GOLD 3,4)
- Breathlessness corresponding to mMRC score ≥ 3
- Informed written consent
- Age ≥ 18 years
- Cognitive relevant, of legal age
- Understands and speaks Danish
- For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial
- For fertile and sexually active subjects: use of safe contraception during medication intake and 4 weeks after: intrauterine device (IUD) or hormonal contraception (oral contraceptive pill, implant, transdermal patch, vaginal ring or depot injection).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Completed |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.