A pragmatic randomised controlled trial to test the efficacy of nortriptyline plus nicotine replacement therapy (NRT) versus a placebo plus NRT in helping smokers to stop and testing the role of noradrenergic and dopaminergic genetic variants in smoking cessation

ISRCTN	ISRCTN57852484
DOI	https://doi.org/10.1186/ISRCTN57852484
Secondary identifying numbers	MREC/03/7/053

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Paul Aveyard
Scientific

Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 8529
Email	p.n.aveyard@bham.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	SCANAG - Smoking Cessation and Nortriptyline and Genetics
Study objectives	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(s)	Ethics approval received from the local medical ethics committee (ref: MREC/03/7/053).
Health condition(s) or problem(s) studied	Smoking cessation
Intervention	NRT plus nortriptyline/placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/08/2003
Completion date	31/07/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	900
Key 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
Key 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
Date of first enrolment	01/08/2003
Date of final enrolment	31/07/2005

Department of Primary Care & General Practice

Birmingham
B15 2TT
United Kingdom

University of Birmingham (UK)
University/education

Dr Brendan Laverty
Research & Enterprise Services
University of Birmingham
Birmingham
B15 2TT
England
United Kingdom

Charity

Cancer Research UK (CRUK) (UK) (ref: C9278/A3461)
Private sector organisation / Other non-profit organizations

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	31/05/2008		Yes	No