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
EudraCT/CTIS number 2006-000106-24
Secondary identifying numbers G0500274 (MRC ref no)
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

King's College London
5 Lambeth Walk
London
SE1 6SP
United Kingdom

Study information

Study designOpen-label, parallel group, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleUsing genotype to tailor prescribing of Nicotine Replacement Therapy (NRT): a randomised controlled trial assessing impact upon medication adherence
Study objectivesAdherence 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) studiedSmoking
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nicotine replacement therapy
Primary outcome measureThe 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 measures1. 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 study start date21/05/2006
Completion date21/05/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants630
Key inclusion criteriaEligible 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 criteria1. 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 enrolment21/05/2006
Date of final enrolment21/05/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College London
London
SE1 6SP
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Research council

Medical Research Council (UK) (ref: G0500274)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 09/11/2010 Yes No
Results article results 01/11/2012 Yes No
Results article results 01/09/2013 Yes No
Results article results 29/01/2018 Yes No

Editorial Notes

14/02/2018: Publication reference added.