| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN14352545 |
| Date ISRCTN assigned | 17/05/2006 |
| Local reference number(s) | G0500274 (MRC ref no) |
| Public title | Using genotype to tailor prescribing of Nicotine Replacement Therapy (NRT): a randomised controlled trial assessing impact upon medication adherence |
| Scientific title |
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| Acronym | The trial is 1 of 3 studies that make up an MRC-funded program of research: GRAB (Genetic Risk And Behaviour change) |
| Disease/condition/study domain | Smoking |
| Study hypothesis | Adherence to NRT is greater when given feedback that NRT is tailored to genotype as opposed to heaviness of smoking |
| Design/methodology | Open-label, parallel group, randomised controlled trial |
| Research ethics review | Added as of 03/08/2007:
Hertfordshire 1 Research Ethics Committee, approved in June 2006 (ref: 06/Q0201/21; Protocol No.1) |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Anticipated start date | 21/05/2006 |
| Anticipated end date | 21/05/2009 |
| Status of trial | Ongoing |
| Target number of participants | 630 participants are required to be randomised |
| 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 | The trial is part of a program of research funded by the Medical Research Council (MRC) (reference G0500274)(UK) |
| Sponsor name | King's College London (UK) |
| Sponsor details | Institute of Psychiatry
De Crespigny Park
London
United Kingdom
SE5 8AF |
| Contact name | Dr David Armstrong |
| Contact details | King's College London
5 Lambeth Walk
London
United Kingdom
SE1 6SP |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN14352545 |
| Date last extracted from ISRCTN register | 17/04/2008 |
