Condition category
Mental and Behavioural Disorders
Date applied
05/07/2005
Date assigned
25/07/2005
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.scanag.bham.ac.uk

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 measures

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

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

http://www.scanag.bham.ac.uk

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18441375

Publication citations

  1. 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.

Additional files

Editorial Notes