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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Denmark
Vejle Hospital - A part of Lillebaelt Hospital
RECRUITING
Vejle
Contact Information
Primary
Sofie K Wolsing, MSc, RN
swolsing@health.sdu.dk
+45 79409055
Backup
Vejle Hospital
Time Frame
Start Date:2025-02-26
Estimated Completion Date:2026-07
Participants
Target number of participants:30
Treatments
Experimental: Dronabinol 20 mg, then placebo
In this arm, the study subject will first receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks.
Placebo_comparator: Placebo, then dronabinol 20 mg
In this arm, the study subject will first receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks.