General practice study of Nicotine Replacement Therapy (NRT) assisted smoking cessation
ISRCTN | ISRCTN05689186 |
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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
Scientific
Smoking Research Group
Department of clinical Pharmacology
University of Oxford
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 6HE
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Nicotine |
Primary outcome measure | 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 study start date | 01/08/2002 |
Completion date | 31/03/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Smoking Research Group
Oxford
OX2 6HE
United Kingdom
OX2 6HE
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
Website | http://www.ox.ac.uk/ |
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https://ror.org/052gg0110 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |