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

ISRCTN	ISRCTN35917266
DOI	https://doi.org/10.1186/ISRCTN35917266
Secondary identifying numbers	12506

Submission date: 05/09/2012
Registration date: 10/09/2012
Last edited: 07/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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
danielle.yuill@manchester.ac.uk

Contact information

Miss Danielle Yuill
Scientific

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email	danielle.yuill@manchester.ac.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of Naltrexone, an Opiate Receptor Antagonist, on capsaicin dose-response in male Healthy volunteers (NORAH)
Study acronym	NORAH
Study objectives	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. Current treatments for chronic cough are ineffective. 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. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12506
Ethics approval(s)	NRES Committee North West - Greater Manchester South, 21/05/2012 ref: 12/NW/0293
Health condition(s) or problem(s) studied	Chronic cough
Intervention	Naltrexone, 50 mg naltrexone tablet or placebo administered to volunteers
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Naltrexone
Primary outcome measure	Effect of naltrexone compared to placebo on maximal capsaicin-induced cough frequency
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/08/2012
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target number of participants	UK Sample Size: 20
Key inclusion criteria	1. Male 2. Aged 18 - 75 years old 3. Normal lung function 4. No current or past history of chronic cough or chronic respiratory illness 5. No current or past history of chronic pain, irritable bowel syndrome or chronic headaches 6. No current or past history of psychiatric illness 7. No current history of reflux disease or post-nasal drip syndrome
Key exclusion criteria	1. Age >75 years 2. Recent upper respiratory tract infection (<4weeks) 3. Use of ACE inhibitors 4. Use of centrally acting medications that may affect the cough reflex 5. History of drug or alcohol abuse 6. Current smoker or ex-smoker with >10 pack year smoking history 7. A previous or current history of liver disease 8. Dependency on opioids 9. Current use of opiates 10. Known hypersensitivity to naltrexone
Date of first enrolment	01/08/2012
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wythenshawe Hospital

Manchester
M23 9LT
United Kingdom

Sponsor information

South Manchester University Hospital (UK)
Hospital/treatment centre

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom

Website	http://www.uhsm.nhs.uk/
"ROR"	https://ror.org/00he80998

Funders

Funder type

Research council

Medical Research Council [MRC] (UK) ref: G0900449
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

07/12/2017: No publications found in PubMed, verifying study status with principal investigator.