Reducing Breathlessness With Dronabinol in COPD Patients

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: COPD, Breathlessness, Cannabis

In brief

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).

Key facts

Study ID

NCT06473701

Run by

Vejle Hospital

People needed

30

Starts

2025-02-26

Expected to finish

2026-10-01

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Vejle Hospital - A part of Lillebaelt Hospital — Vejle, Region Syddanmark, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.