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ISRCTN
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ISRCTN14352545
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ClinicalTrials.gov identifier
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Public title
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Using genotype to tailor prescribing of Nicotine Replacement Therapy (NRT): a randomised controlled trial assessing impact upon medication adherence
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Scientific title
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Acronym
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The trial is 1 of 3 studies that make up an MRC-funded program of research: GRAB (Genetic Risk And Behaviour change)
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Serial number at source
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G0500274 (MRC ref no)
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Study hypothesis
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Adherence to NRT is greater when given feedback that NRT is tailored to genotype as opposed to heaviness of smoking
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Ethics approval
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Added as of 03/08/2007:
Hertfordshire 1 Research Ethics Committee, approved in June 2006 (ref: 06/Q0201/21; Protocol No.1)
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Study design
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Open-label, parallel group, 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
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Participants - inclusion criteria
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Eligible participants are:
1. Motivated quitters attending the participating NHS smoking cessation clinics
2. Participants must be smokers smoking 10 or more cigarettes per day over the last 12 months
3. Aged 18 and over
4. Living in the British Isles
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Participants - exclusion criteria
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1. Non-smokers
2. Smokers smoking less than 10 cigarettes daily over the last 12 months
3. Aged under 18
4. Living outside the British Isles
5. Cigar/pipe smokers
6. NRT contraindications (e.g. pregnant or lactating women)
7. Those with previous severe adverse reactions to NRT
8. Currently taking medication for smoking cessation that they are unwilling to cease taking or medication with a known influence on smoking cessation that they cannot stop
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Anticipated start date
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21/05/2006
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Anticipated end date
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21/05/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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630 participants are required to be randomised
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Interventions
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Participants will be divided into two groups of equal size by randomisation. One group will be informed that prescribing for NRT is based upon DNA information and addiction, and the other group informed that it is based on addiction alone.
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Primary outcome measure(s)
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The proportion of all NRT consumed in the first 4 weeks of quitting or to the point of relapse, whichever is the sooner. This will be measured by self-report daily diary, backed up by 'pill count reconciliation' with the diary at the clinic. If pill counts are discrepant with the diary, this will be discussed and reconciled at the clinic visit.
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Secondary outcome measure(s)
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1. Responses to the Mood and Physical Symptoms Scale, a measure of nicotine withdrawal symptoms
2. Point prevalance of 14-day complete abstinence measured at 28 days after smoking cessation
3. Response efficacy of NRT
4. State anxiety
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Sources of funding
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The trial is part of a program of research funded by the Medical Research Council (MRC) (reference G0500274)(UK)
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Trial website
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Publications
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Contact name
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Dr
David
Armstrong
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Address
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King's College London
5 Lambeth Walk
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City/town
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London
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Zip/Postcode
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SE1 6SP
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Country
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United Kingdom
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Sponsor
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King's College London (UK)
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Address
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Institute of Psychiatry
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Date applied
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20/03/2006
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Last edited
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03/08/2007
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Date ISRCTN assigned
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17/05/2006
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