RecruitingPhase 3NCT06473701

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

Sponsor

Vejle Hospital

Enrollment

30 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

COPD Breathlessness Cannabis

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

Min Age: 18 Years

Inclusion Criteria9

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).

Exclusion Criteria6

Ongoing infection or exacerbation of COPD within the last month (30 days)
Regular treatment with THC or CBD within 1 month (30 days)
Life expectancy less than 3 months (90 days)
Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19
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
Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study