The effect of Naltrexone, an Opiate Receptor Antagonist, on capsaicin dose-response in male Healthy volunteers (NORAH)

Update Il y a 5 ans
Reference: ISRCTN35917266

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Extract

Background and study aims Coughing is extremely common and has a major impact on quality of life. Some people develop persistent coughing (more than 8 weeks in duration) which is called chronic cough. The current treatments for chronic cough are not effective. To develop better treatments we would like to understand how coughing can normally be controlled in healthy people. Coughing can be induced by breathing in an extract of chilli pepper (called capsaicin). This is entirely safe, and has been used in several research studies. Our previous research has shown that healthy people tend to cough much less than patients with a cough after they have inhaled capsaicin, but we do not yet understand why this is. We believe that when healthy people inhale capsaicin, morphine-like substances may be released in the brain. These morphine-like substances may reduce coughing by acting on certain brain receptors, known as opiate receptors. We think that by blocking these opiate receptors using a drug called naltrexone, healthy people would temporarily cough more than usual. Who can participate? We will need 15 male healthy volunteers to take part in this study. What does the study involve? The study will involve two visits at least 1 week apart. Each visit will last about 2 hours. At one of the visits, the volunteer will take a tablet containing naltrexone, and at the other visit the volunteer will take a tablet that contains no active drug (called a placebo). The study doctor will not know which tablet the volunteer takes during the study visits (known as blinding). During each visit the volunteer will inhale capsaicin so that we can measure how much they cough and be asked to complete a questionnaire about their urge to cough. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? North West Lung Research Centre at Wythenshawe Hospital (UK). When is the study starting and how long is it expected to run for? August 2012 to April 2013. Who is funding the study? Medical Research Council (UK). Who is the main contact? Danielle Yuill [email protected]


Inclusion criteria

  • Chronic Cough

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