Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Paul Aveyard
ORCID ID
Contact details
Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8529
p.n.aveyard@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MREC/03/7/053
Study information
Scientific title
Acronym
SCANAG - Smoking Cessation and Nortriptyline and Genetics
Study hypothesis
1. To show whether nortriptyline plus NRT is more effective than NRT alone in smoking cessation
2. To explore whether allelic variants coding for components of the noradrenergic pathways interact with pharmacological treatment and are related to withdrawal severity and successful quitting
3. To test a previous exploratory finding that allelic variants coding for components of the dopaminergic pathways interact with NRT to predict quitting success
Ethics approval
Ethics approval received from the local medical ethics committee (ref: MREC/03/7/053).
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
NRT plus nortriptyline/placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Nortriptyline and nicotine replacement therapy (NRT)
Primary outcome measure
Six months of continuous abstinence biochemically confirmed.
Secondary outcome measures
1. Seven-day point prevalence
2. Twelve-month continuous abstinence
Overall trial start date
01/08/2003
Overall trial end date
31/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Smoked at least 10 cigarettes per day on average over the past year.
2. Want to quit
3. Prepared to use NRT and the trial drug
4. Using an NHS stop smoking service
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
900
Participant exclusion criteria
1. Pregnant or breast feeding or planning to do so in the next 3 months
2. Not clinically suitable to use NRT according to data sheet
3. Not clinically suitable to use nortriptyline according to data sheet
Recruitment start date
01/08/2003
Recruitment end date
31/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Dr Brendan Laverty
Research & Enterprise Services
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8529
p.n.aveyard@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C9278/A3461)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18441375
Publication citations
-
Results
Aveyard P, Johnson C, Fillingham S, Parsons A, Murphy M, Nortriptyline plus nicotine replacement versus placebo plus nicotine replacement for smoking cessation: pragmatic randomised controlled trial., BMJ, 2008, 336, 7655, 1223-1227, doi: 10.1136/bmj.39545.852616.BE.