Using Dronabinol to Reduce Breathlessness 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

This study is testing if Dronabinol can help people with severe COPD breathe easier compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vejle Hospital (other)
• Locations: 1 site (Vejle, Region Syddanmark)
• Trial ID: NCT06473701 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Dronabinol, a synthetic form of THC, in alleviating severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD). It is designed as a randomized, controlled, double-blind, crossover trial where participants will receive both Dronabinol and a placebo in a blinded sequence over four weeks, with a two-week washout period in between. Participants will complete questionnaires about their breathlessness experiences and undergo various health assessments, including lung function tests and blood sample collections. The goal is to determine if Dronabinol can significantly reduce breathlessness compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with severe COPD who experience refractory dyspnea despite optimal treatment.

Not a fit: Patients with ongoing infections, recent exacerbations of COPD, or those currently using THC or CBD may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief from breathlessness for patients suffering from severe COPD.

How similar studies have performed: While the use of cannabis-based medicine in COPD is a relatively novel approach, preliminary studies have shown potential benefits, suggesting this trial could contribute valuable insights.

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 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

Where this trial is running

Vejle, Region Syddanmark

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

Study contacts

• Principal investigator: Ole Hilberg, Prof., MD — Medical Department, Vejle Hospital
• Study coordinator: Sofie K Wolsing, MSc, RN

Conditions: COPD, Breathlessness, Cannabis, Randomized, Controlled, Double-blind, Crossover trial, Cannabis-based medicine