Condition category
Mental and Behavioural Disorders
Date applied
12/10/2005
Date assigned
16/11/2005
Last edited
20/12/2011
Prospective/Retrospective
Retrospectively 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 Michael Murphy

ORCID ID

Contact details

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

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

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

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

  1. 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.

Additional files

Editorial Notes