Recruiting
Phase 2

Morphine with Exercise

Sponsor:

Dennis Jensen, Ph.D.

Code:

NCT03824834

Conditions

Chronic Obstructive Pulmonary Disease

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

Exercise training with morphine

Exercise training with placebo

Study Details

Brief summary:

The purpose of this study is to explore the role of low-dose immediate-release oral morphine as a novel adjunct pharmacotherapy to enable symptomatic adults with advanced chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) to exercise at higher intensities for longer durations and maximize the psycho-physiological benefits of a supervised exercise training program. We hypothesize that, compared to placebo, exercise training with oral morphine will result in relatively greater improvements in exercise endurance time and intensity ratings of perceived breathlessness during constant-load cardiopulmonary cycle exercise testing (CPET) at 75% of peak power output (PPO).

Conditions

Chronic Obstructive Pulmonary Disease

Interstitial Lung Disease

Study ID

NCT03824834

Start date

Aug 6, 2019

Status verified date

Aug, 2019

Completion date

Nov, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and females aged 35 years and over
  • Clinical diagnosis of COPD or ILD
  • Cigarette smoking history ≥20 years (COPD only)
  • Post bronchodilator FEV1 <50% predicted and FEV1/FVC <0.70 (COPD only)
  • Chronic breathlessness syndrome (modified Medical Research Council dyspnea score ≥3; Baseline Dyspnea Index focal score ≤6; and/or an Oxygen Cost Diagram rating ≤50% full scale despite optimal treatment of the underlying pathophysiology according to evidence-based clinical practice guidelines
  • Report breathlessness as the main limiting factor to incremental CPET
  • Body mass index >18.5 kg/m2 and <35 kg/m2

Exclusion Criteria:

  • Changed respiratory medication dosage and/or frequency of administration in preceding two weeks
  • Disease exacerbation/hospitalization in preceding six weeks
  • Arterialized capillary CO2 tension (PacCO2) >50 mmHg at rest
  • Self-reported history of drug addiction and/or substance abuse assessed with the CAIG-aid and SISAP questionnaires
  • Severe excessive daytime sleepiness assessed with the Epworth Sleepiness Scale (score of 16 out of 24)
  • Currently use anti-seizure and/or opioid drug(s)
  • Use daytime supplemental oxygen
  • Exercise-induced oxyhemoglobin desaturation to <80% on room air
  • Participated in a pulmonary rehabilitation program in preceding 6 months
  • Allergy/sensitivity to opioid drugs
  • Significant extra-pulmonary disease that could impair exercise tolerance
  • Contraindication(s) to cardiopulmonary exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease)
  • Pregnant or currently trying to become pregnant: women of child bearing potential (defined as having a menstrual period within the last 12 months) will be required to take a routine (urine) pregnancy test to rule out the possibility of pregnancy
  • Self-report any of the following conditions: anemia or abnormally low blood volume; asthma; hypothyroidism; Addison's disease; renal insufficiency; hypopituitarism; severe malnutrition; digestive disease (any form of colitis disease); prostatic hypertrophy or urethral stricture
  • Use of the blood thinning (anti-coagulant) drug Coumadin, Pradaxa, Xarelto and Eliquis in previous 2 weeks

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise training with morphine

Immediate-release oral morphine (syrup, 0.1 mg/kg body mass to a maximum dose of 10 mg) with supervised exercise training.

placebo comparator: Exercise training with placebo

Placebo treatment with supervised exercise training.

Interventions

Exercise training with morphine

Immediate-release oral morphine (syrup, 0.1 mg/kg body mass to a maximum dose of 10 mg) prepared in 250 mL of orange juice 30-min prior to each exercise session. Participants will complete exercise training sessions (three times per week for five weeks) on an electronically braked bike, supervised by a trained exercise specialist. Exercise sessions will be individualized based on participants' peak power output (60% PPO) determined from incremental exercise testing, and progressed to ensure the participant is exercising at a breathlessness intensity rating of between 3-5 Borg CR10 scale units and can complete at least 20-min of continuous cycling. Exercise duration will be increased in 5-min intervals up to 40-min. Thereafter, exercise intensity will be increased by 5-15% of baseline PPO.

Exercise training with placebo

Diluted simple syrup prepared in 250 mL of orange juice 30-min prior to each exercise session. Participants will complete exercise training sessions as per the experimental group.

Primary outcome measure

  • Cardiopulmonary exercise testing (CPET) endurance time [ Time Frame: Immediately after exercise training program ]
  • Borg modified 0-10 category ratio scale (Borg CR10) for breathlessness intensity [ Time Frame: Immediately after exercise training program ]

Central Contacts and Locations

Central contacts

Dennis Jensen, Ph.D

514-398-4184denis.jensen@mcgill.ca

Hayley Lewthwaite, Ph.D

514-398-4184hayley.lewthwaite@mail.mcgill.ca

Locations

Montreal Chest Institute of the McGill University Health Center (MUHC)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Dennis Jensen, Ph.D.

514-398-4184dennis.jensen@mcgill.ca

Hayley Lewthwaite, Ph.D

514-398-4184hayley.lewthwaite@mail.mcgill.ca

Principal Investigator:

Dennis Jensen, Ph.D.

More Information

Sponsor

Dennis Jensen, Ph.D.

Last update posted

Aug 16, 2019

Last verified

Aug, 2019

Keywords

  • Breathlessness
  • Dyspnea
  • Exercise
  • Opioids
  • Morphine
  • Exercise tolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dennis Jensen, Ph.D. on 2019-08-16.