Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0032117035
Study information
Scientific title
Acronym
Patch In Practice (PIP)
Study hypothesis
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
Not provided at time of registration
Study design
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 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 names
Nicotine
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
01/08/2002
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
1. Pregnant or breast feeding
2. Using NRT or Zyban
Recruitment start date
01/08/2002
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Smoking Research Group
Oxford
OX2 6HE
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
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
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17483139
Publication citations
-
Results
Aveyard P, Brown K, Saunders C, Alexander A, Johnstone E, Munafò MR, Murphy M, Weekly versus basic smoking cessation support in primary care: a randomised controlled trial., Thorax, 2007, 62, 10, 898-903, doi: 10.1136/thx.2006.071837.