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Using genotype to tailor prescribing of Nicotine Replacement Therapy (NRT): a randomised controlled trial assessing impact upon medication adherence
ISRCTN ISRCTN14352545
DOI 10.1186/ISRCTN14352545
ClinicalTrials.gov identifier
EudraCT number 2006-000106-24
Public title Using genotype to tailor prescribing of Nicotine Replacement Therapy (NRT): a randomised controlled trial assessing impact upon medication adherence
Scientific title
Acronym N/A
Serial number at source G0500274 (MRC ref no)
Study hypothesis Adherence to NRT is greater when given feedback that NRT is tailored to genotype as opposed to heaviness of smoking.

The trial is 1 of 3 studies that make up an MRC-funded programme of research: GRAB (Genetic Risk And Behaviour change)
Lay summary Not provided at time of registration
Ethics approval Added as of 03/08/2007:
Hertfordshire 1 Research Ethics Committee, approved in June 2006 (ref: 06/Q0201/21; Protocol No.1)
Study design Open-label, parallel group, randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Smoking
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 21/05/2006
Anticipated end date 21/05/2009
Status of trial Completed
Patient information material
Target number of participants 630
Interventions 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.
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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
Sources of funding Medical Research Council (UK) (ref: G0500274)
Trial website
Publications 1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21062464
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22509402
3. 2013 results in http://ntr.oxfordjournals.org/content/early/2013/02/18/ntr.ntt010.abstract
Contact name Dr  David  Armstrong
  Address King's College London
5 Lambeth Walk
  City/town London
  Zip/Postcode SE1 6SP
  Country United Kingdom
Sponsor King's College London (UK)
  Address Institute of Psychiatry
De Crespigny Park
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
Date applied 20/03/2006
Last edited 20/02/2013
Date ISRCTN assigned 17/05/2006
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