General practice study of Nicotine Replacement Therapy (NRT) assisted smoking cessation

ISRCTN ISRCTN05689186
DOI https://doi.org/10.1186/ISRCTN05689186
Secondary identifying numbers N0032117035
Submission date
12/10/2005
Registration date
16/11/2005
Last edited
20/12/2011
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 Michael Murphy
Scientific

Smoking Research Group
Department of clinical Pharmacology
University of Oxford
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 6HE
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymPatch In Practice (PIP)
Study objectives1. Assess whether extremes of behavioural support make a difference to quit rates
2. Study whether an individual's response to NRT is influenced by genetic constitution
3. Describe the relationship between nicotine load whilst smoking and that derived from transdermal patch
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSmoking cessation
InterventionPIP is an open randomised controlled trial of two levels of behavioural support. One of the aims of the study is to assess response of moderately addicted smokers making a Nicotine Replacement Therapy (NRT) assisted quit attempt when randomised to low or moderate behavioural support within general practice.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nicotine
Primary outcome measureContinuous abstinence by self-report and carbon dioxide at 1 week, 4 weeks, and 12 weeks in relation to genotype and 4 weeks for replacement.
Secondary outcome measures1. Continuous abstinence at 1, 3, 6 and 12 months
2. Point prevalence abstinence at 1 week, 4 weeks, 3, 6 and 12 months by self report
Overall study start date01/08/2002
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1000
Key inclusion criteria1. Greater than 18 years of age
2. Smoke 10 or more cigarettes per day
3. Wish to try to give up completely
Key exclusion criteria1. Pregnant or breast feeding
2. Using NRT or Zyban
Date of first enrolment01/08/2002
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Smoking Research Group
Oxford
OX2 6HE
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Website http://www.ox.ac.uk/
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
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?
Results article Results 01/10/2007 Yes No