Reducing Breathlessness With Dronabinol in COPD Patients
Recruiting
Phase 3Interventional Study
COPDBreathlessnessCannabis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
30 (estimated)
Sponsor
Vejle Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 tha…
Inclusion Criteria:
* 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 Criteria:
* 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
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