Reducing Breathlessness With Dronabinol in COPD Patients

NCT06473701 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-513593-22-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COPD; Breathlessness; Cannabis

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

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

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

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

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

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

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

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

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

• 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

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

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

Secondary Outcomes (12)

• Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period

  Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)

• Difference in COPD Assessment Test questionnaire score between active treatment and placebo period

  Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)

• Difference in Chronic Respiratory Disease Questionnaire score between active treatment and placebo period

  Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)

• Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period

  Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)

• Difference in Medical Research Council Dyspnea Scale questionnaire score between active treatment and placebo period

  Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)

Other Outcomes (2)

• Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.

  Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)

• Difference in stand-to-sit-test between active treatment and placebo

  Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)

Study Arms (2)

Dronabinol 20 mg, then placebo

EXPERIMENTAL

In this arm, the study subject will first receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks.

Drug: Dronabinol 2.5mg Capsule; Drug: Placebo

Placebo, then dronabinol 20 mg

PLACEBO COMPARATOR

In this arm, the study subject will first receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks.

Drug: Dronabinol 2.5mg Capsule; Drug: Placebo

Interventions

Dronabinol 2.5mg Capsule DRUG

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

Also known as: Delta9-tetrahydrocannabinol

Dronabinol 20 mg, then placebo; Placebo, then dronabinol 20 mg

Placebo DRUG

Dronabinol-matched placebo capsule containing no active substance.

Dronabinol 20 mg, then placebo; Placebo, then dronabinol 20 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vejle Hospital: lead
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator
• Odense Patient Data Explorative Network: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Vejle Hospital - A part of Lillebaelt Hospital

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

Related Publications (1)

• Wolsing SK, Hilberg O, Lokke A, Farver-Vestergaard I, Andersen CU, Hansen KK. Reducing severe breathlessness with dronabinol in the group of patients with severe and very severe chronic obstructive pulmonary disease (BONG): a randomised, double-blinded, placebo-controlled, crossover study in an outpatient clinic in Denmark - a study protocol. BMJ Open. 2026 Feb 16;16(2):e104957. doi: 10.1136/bmjopen-2025-104957.

  PMID: 41698715 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ole Hilberg, Prof., MD

  Medical Department, Vejle Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie K Wolsing, MSc, RN

CONTACT

+45 79409055; swolsing@health.sdu.dk

Vejle Hospital

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An external party will manage the randomization process, assigning participants equally to either the active treatment or placebo groups in a 1:1 ratio. The randomization will be conducted using www.sealedenvelope.com and will incorporate varying block sizes, such as 4, 6, and 8 participants per block. Consequently, each medication container will be labeled with a unique participant number.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, controlled, double-blind, crossover trial

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 25, 2024
• Study Start: February 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)