Additional identifiers
EudraCT number
2006-000106-24
ClinicalTrials.gov number
Protocol/serial number
G0500274 (MRC ref no)
Study information
Scientific title
Using genotype to tailor prescribing of Nicotine Replacement Therapy (NRT): a randomised controlled trial assessing impact upon medication adherence
Acronym
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)
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Nicotine replacement therapy
Primary outcome measure
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 measures
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
Overall trial start date
21/05/2006
Overall trial end date
21/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
630
Participant 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
Recruitment start date
21/05/2006
Recruitment end date
21/05/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 6SP
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) (ref: G0500274)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
4. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29385578
Publication citations
-
Protocol
Marteau TM, Munafò MR, Aveyard P, Hill C, Whitwell S, Willis TA, Crockett RA, Hollands GJ, Johnstone EC, Wright AJ, Prevost AT, Armstrong D, Sutton S, Kinmonth AL, Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence., BMC Public Health, 2010, 10, 680, doi: 10.1186/1471-2458-10-680.
-
Results
Marteau TM, Aveyard P, Munafò MR, Prevost AT, Hollands GJ, Armstrong D, Sutton S, Hill C, Johnstone E, Kinmonth AL, Effect on adherence to nicotine replacement therapy of informing smokers their dose is determined by their genotype: a randomised controlled trial., PLoS ONE, 2012, 7, 4, e35249, doi: 10.1371/journal.pone.0035249.