None listed
Conditions
Brief summary
The purpose of this study is to determine the effects of sustained-release oral morphine (20mg) on sleep efficiency, breathlessness, and daytime alertness in breathless people with chronic obstructive pulmonary disease. We hypothesize that low dose morphine will improve sleep efficiency.
Interventions
The primary aim of this randomised double-blind placebo-controlled cross-over study of sustained-release oral morphine 20mg daily for 3 days in a row versus placebo (oral, daily for 3 days in a row) is to determine the effect of morphine on sleep quality, as measured by sleep efficiency, in community-dwelling people with chronic obstructive pulmonary disease (COPD). Sleep efficiency will be determined by the percentage of time spent sleeping whilst in bed during an overnight sleep study in the A
The primary aim of this randomised double-blind placebo-controlled cross-over study of sustained-release oral morphine 20mg daily for 3 days in a row versus placebo (oral, daily for 3 days in a row) is to determine the effect of morphine on sleep quality, as measured by sleep efficiency, in community-dwelling people with chronic obstructive pulmonary disease (COPD). Sleep efficiency will be determined by the percentage of time spent sleeping whilst in bed during an overnight sleep study in the Adelaide Institute for Sleep Health laboratory. Twenty-two participants will be recruited from Flinders Medical Centre (FMC) respiratory clinics, the nurse-led home outreach program, or the South Adelaide Local Health Network (SALHN) pulmonary rehabilitation and airway clearance programs. Secondary aims include subjective (questionnaire) assessments of sleep quality, subjective and objective assessments of breathlessness, blood tests to assess individuals’ morphine concentration and genetic polymorphisms, and alertness as measured by 30 minute driving simulator performance in the morning after the overnight in-lab sleep study. Participants will attend the sleep lab on the night following the third dose of study medication on both the placebo and morphine weeks. There will be a minimum four-day washout period after the first overnight sleep study before the second study drug period (either morphine or placebo) commences. In addition to morphine concentration testing, we will request drug tablet return at the end of the study to further monitor adherence.
Sponsors
Adelaide Institute for Sleep Health, Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged 18 years and older - Chronic Obstructive Pulmonary Disease (COPD) - Chronic breathlessness syndrome (as defined as a modified Medical Research Council breathlessness score of 2 or more) - Optimal pharmacological treatment based on Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) 2021 Report - An Australia-modified Karnofsky Performance Status (AKPS) scale score greater than or equal to 40
Exclusion criteria
- Concurrent use of opioids, benzodiazepines, or monoamine-oxidase inhibitors, or within 7 days of such therapy - Body mass index >40kg/m2 - Prior diagnosis of severe obstructive sleep apnea (apnea-hypopnea index more than 30 events/hr) - Uncontrolled nausea, vomiting, or gastrointestinal obstruction - Calculated creatinine clearance <25mL/min - Two or more hepatic enzyme greater than or equal to 3 times the upper limit of normal - International normalised ratio >1.2 in the absence of warfarin - Unresolved cardiac or respiratory event in the past 7 days (excluding upper respiratory tract infections) - Anaemia for which a blood transfusion was indicated for breathlessness in the past 12 months - Pregnant, or childbearing potential not using contraception - Breastfeeding - Waiting list for lung transplantation - Change in COPD medications in the past 7 days (except "as needed" medications) - Use of home non-invasive ventilation (NIV) - History of endotracheal intubation for respiratory failure - History of severe COPD exacerbation requiring acute NIV - History of opioid-related respiratory failure - History of opioid dependence (as per the International Classification of Diseases and Health Problems (ICD-10) definition) - Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation
Outcome results
None listed