Condition category
Mental and Behavioural Disorders
Date applied
20/03/2006
Date assigned
17/05/2006
Last edited
20/02/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Armstrong

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2006-000106-24

ClinicalTrials.gov number

Protocol/serial number

G0500274 (MRC ref no)

Study information

Scientific title

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 measures

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

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

Sponsor information

Organisation

King's College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) (ref: G0500274)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes