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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Michael Murphy
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Patch In Practice (PIP)
Study objectives	1. 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) studied	Smoking cessation
Intervention	PIP 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 type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Nicotine
Primary outcome measure(s)	Continuous abstinence by self-report and carbon dioxide at 1 week, 4 weeks, and 12 weeks in relation to genotype and 4 weeks for replacement.
Key secondary outcome measure(s)	1. 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
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1000
Key inclusion criteria	1. Greater than 18 years of age 2. Smoke 10 or more cigarettes per day 3. Wish to try to give up completely
Key exclusion criteria	1. Pregnant or breast feeding 2. Using NRT or Zyban
Date of first enrolment	01/08/2002
Date of final enrolment	31/03/2006

Smoking Research Group

Oxford
OX2 6HE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/10/2007		Yes	No