Morphine And BrEathLessness trial (MABEL)
Research type
Research Study
Full title
A parallel group, double-blind, randomised, placebo-controlled trial comparing the effectiveness and cost effectiveness of low dose oral modified release morphine versus placebo on patient-reported worst breathlessness in people with chronic breathlessness.
IRAS ID
263087
Contact name
Miriam Johnson
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Eudract number
2019-002479-33
ISRCTN Number
ISRCTN87329095
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Chronic breathlessness affects most people with advanced lung and heart diseases, often disabling despite best treatments of the underlying condition(s). Studies of a few days of regular, low doses of ”long-acting” morphine show that this can help reduce chronic breathlessness safely, but we don't know if it keeps working, or does any harm, in the longer term.
We will find out if regular, low dose morphine capsules regularly twice daily are better than placebo (dummy) ones for chronic breathlessness in 158 people and, if it works, the best ways to provide long-acting morphine to people who need it.
People with fully treated disease still causing chronic breathlessness participating in the study will be chosen randomly to have either morphine or a placebo capsule twice a day for two months. After two weeks, the dose will be increased if breathlessness isn’t improving and they don’t want to stop because of side-effects. At the end, participants may try morphine as part of their usual care. We will judge success on how participants’ worst daily breathlessness feels. We will also measure physical activity, quality of life, sleep quality, side-effects, overall ability to function, use of healthcare services and - as the study includes people with serious illness - survival. Family members will be able to help by completing questionnaires about the impact of caring on them. Alongside the study, we will ask clinicians and study participants about issues which would help or hinder patients to have regular, low dose morphine for breathlessness if the study shows it is the better treatment.
If morphine is shown to help, and doesn’t harm, we want all suitable patients to have access to it and used carefully, in accordance with the evidence.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0284
Date of REC Opinion
3 Dec 2019
REC opinion
Further Information Favourable Opinion