Using genotype to tailor prescribing of Nicotine Replacement Therapy (NRT): a randomised controlled trial assessing impact upon medication adherence
| ISRCTN | ISRCTN14352545 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14352545 |
| Clinical Trials Information System (CTIS) | 2006-000106-24 |
| Protocol serial number | G0500274 (MRC ref no) |
| Sponsor | King's College London (UK) |
| Funder | Medical Research Council (UK) (ref: G0500274) |
- Submission date
- 20/03/2006
- Registration date
- 17/05/2006
- Last edited
- 14/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Armstrong
Scientific
Scientific
King's College London
5 Lambeth Walk
London
SE1 6SP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label, parallel group, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Using genotype to tailor prescribing of Nicotine Replacement Therapy (NRT): a randomised controlled trial assessing impact upon medication adherence |
| Study objectives | 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) |
| Ethics approval(s) | Added as of 03/08/2007: Hertfordshire 1 Research Ethics Committee, approved in June 2006 (ref: 06/Q0201/21; Protocol No.1) |
| Health condition(s) or problem(s) studied | Smoking |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nicotine replacement therapy |
| 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. |
| Key secondary outcome measure(s) |
1. Responses to the Mood and Physical Symptoms Scale, a measure of nicotine withdrawal symptoms |
| Completion date | 21/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 630 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/05/2006 |
| Date of final enrolment | 21/05/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's College London
London
SE1 6SP
United Kingdom
SE1 6SP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2012 | Yes | No | |
| Results article | results | 01/09/2013 | Yes | No | |
| Results article | results | 29/01/2018 | Yes | No | |
| Protocol article | protocol | 09/11/2010 | Yes | No |
Editorial Notes
14/02/2018: Publication reference added.
