INTERVENTIONALACTIVE NOT RECRUITINGNCT06473701

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 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).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-28

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 30 (ESTIMATED)
Start date: 2025-02-26
Sponsor: Vejle Hospital
Design: RANDOMIZED · CROSSOVER · SUPPORTIVE CARE
Locations: 1
Results record: Not present in registry snapshot

This study is a randomized, controlled, double-blind, crossover trial evaluating the effectiveness of the pharmaceutical drug Dronabinol in patients with severe and very severe COPD. The researchers will compare the effects of Dronabinol with a placebo (an identical-looking substance that contains no active drug) to determine if Dronabinol reduces breathlessness in COPD patients. After enrollment, study subjects will undergo four weeks of treatment with both Dronabinol and the placebo in a blinded and randomized sequence. There is a two-week washout period between treatments. During these treatment phases, subjects will complete questionnaires about their daily experiences of breathlessness and wear a watch that records various health parameters. The study includes eight visits: the initial enrollment and follow-up checks every two weeks. At these visits, subjects undergo tests for lung function and walking distance, and complete health status questionnaires. Additionally, blood samples for THC levels and hair samples for cortisol analysis are collected.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol

Medicines

DRONABINOL DRONABINOL DRONABINOL DRONABINOL

Interventions

What was registered

DRUG

Dronabinol 2.5mg Capsule

Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.

Delta9-tetrahydrocannabinol

DRUG

Placebo

Dronabinol-matched placebo capsule containing no active substance.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

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

primary outcomes

primary measures

Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo

Time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days

Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness

Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo

Time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days

Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities

Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period

Time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days

Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness

Correlation between breathlessness interference of daily activities rated on a numeric rating scale in relation to amount of THC blood level of the active treatment period

Time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days

Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities

secondary outcomes