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ISRCTN
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ISRCTN57852484
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ClinicalTrials.gov identifier
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Public title
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A pragmatic randomised controlled trial to test the efficacy of nortriptyline plus nicotine replacement therapy (NRT) versus a placebo plus NRT in helping smokers to stop and testing the role of noradrenergic and dopaminergic genetic variants in smoking cessation
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Scientific title
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Acronym
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SCANAG - Smoking Cessation and Nortriptyline and Genetics
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Serial number at source
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MREC/03/7/053
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Study hypothesis
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1. To show whether nortriptyline plus NRT is more effective than NRT alone in smoking cessation
2. To explore whether allelic variants coding for components of the noradrenergic pathways interact with pharmacological treatment and are related to withdrawal severity and successful quitting
3. To test a previous exploratory finding that allelic variants coding for components of the dopaminergic pathways interact with NRT to predict quitting success
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics approval received from the local medical ethics committee (ref: MREC/03/7/053).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Smoking cessation
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Participants - inclusion criteria
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1. Smoked at least 10 cigarettes per day on average over the past year.
2. Want to quit
3. Prepared to use NRT and the trial drug
4. Using an NHS stop smoking service
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Participants - exclusion criteria
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1. Pregnant or breast feeding or planning to do so in the next 3 months
2. Not clinically suitable to use NRT according to data sheet
3. Not clinically suitable to use nortriptyline according to data sheet
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Anticipated start date
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01/08/2003
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Anticipated end date
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31/07/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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900
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Interventions
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NRT plus nortriptyline/placebo.
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Primary outcome measure(s)
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Six months of continuous abstinence biochemically confirmed.
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Secondary outcome measure(s)
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1. Seven-day point prevalence
2. Twelve-month continuous abstinence
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Sources of funding
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Cancer Research UK (CRUK) (UK) (ref: C9278/A3461)
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Trial website
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http://www.scanag.bham.ac.uk
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18441375
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Contact name
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Dr
Paul
Aveyard
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Address
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Department of Primary Care & General Practice
University of Birmingham
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 8529
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Email
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p.n.aveyard@bham.ac.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Dr Brendan Laverty
Research & Enterprise Services
University of Birmingham
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 8529
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Email
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p.n.aveyard@bham.ac.uk
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Sponsor website:
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http://www.scanag.bham.ac.uk
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Date applied
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05/07/2005
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Last edited
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21/12/2011
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Date ISRCTN assigned
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25/07/2005
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