RecruitingPhase 3ACTRN12609000209291

Opioids for breathlessness in people with primary hypertension.

Randomised, placebo-controlled, double-blind, cross-over study of the efficacy of sustained-release low dose morphine in the subjective sensation of dyspnoea due to maximally treated primary pulmonary hypertension in opioid naive participants.


Sponsor

Flinders University - Department of Palliative and Support Services

Enrollment

40 participants

Start Date

Apr 21, 2009

Study Type

Interventional

Conditions

Summary

Dyspnoea is a source of physical and psychological distress, and is one of the most commonly feared aspects of the dying process. By definition, people with severe primary pulmonary hypertension have breathlessness, despite maximal therapy and recent advances in therapies for primary pulmonary hypertension. In parallel with attempting to treat the underlying pathology causing breathlessness, the sensation of breathlessness itself must be ameliorated. For many participants there comes a point when there are no further identifiable reversible components of the disease and the full focus of care moves to reducing the subjective sensation of breathlessness. Opioids have been studied for the relief of breathlessness predominantly in people with chronic obstructive pulmonary disease although people with cancer and heart failure have been included. [Abernethy, Miriam Johnson] A meta-analysis verified that overall there is benefit from the use of morphine in people with refractory breathlessness. [Jennings] This prospective, randomised, placebo-controlled, double-blind, cross-over study is modelled on a study successfully undertaken by some members of this research team. The study proposes to specifically study people with primary pulmonary hypertension for whom breathlessness is a significant symptomatic problem to establish whether there is benefit from sustained release morphine, and if so, what magnitude of benefit, and the clinical characteristics of those who are most likely to respond to this intervention. Any toxicity will also be carefully monitored.Study participants will receive either Kapanol 20mg and Coloxyl and Senna 1 to 2 tablets, or kapanol placebo and coloxyl and senna placebo for one week, will receive no intervention medication for the second week then will receive the alternative intervention combination for the third week.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a low dose of slow-release morphine can relieve the feeling of breathlessness (difficulty breathing) in people with severe primary pulmonary hypertension — a serious condition that raises blood pressure in the lungs and makes breathing very hard despite the best available treatments. The study uses a crossover design: participants will take either morphine or a placebo for one week, have a break, then take the other option — so everyone experiences both. Researchers are looking at whether morphine reduces the distressing sensation of breathlessness. You may be eligible if: - You are 18 years or older - You have primary pulmonary hypertension and breathlessness despite maximum medical treatment - Your condition is rated NYHA class III or IV (severely limiting daily activities) - Your kidney function, blood levels, and medications have been stable for at least 7 days - You are able to complete a daily diary and give informed consent You may NOT be eligible if: - You already take regular opioid pain medicines - You have had a bad reaction to morphine in the past - You have a history of central breathing problems (central hypoventilation syndrome) - You have taken MAOIs (a type of antidepressant) in the past 2 weeks - You are confused, have significant cognitive impairment, or have uncontrolled nausea, vomiting, or bowel obstruction - You are pregnant, breastfeeding, or at risk of pregnancy - You have a significant history of opioid misuse Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

One capsule of sustained- release Morphine 20mg taken orally, daily for 7 days, 1-2 tablets of Coloxyl and Senna taken orally, daily for 7 days, then a washout period of one week.

One capsule of sustained- release Morphine 20mg taken orally, daily for 7 days, 1-2 tablets of Coloxyl and Senna taken orally, daily for 7 days, then a washout period of one week.


Locations(1)

Austin Health - Austin Hospital - Heidelberg

Australia

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ACTRN12609000209291