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 |
| Protocol serial number | MREC/03/7/053 |
| Sponsor | University of Birmingham (UK) |
| Funder | Cancer Research UK (CRUK) (UK) (ref: C9278/A3461) |
- Submission date
- 05/07/2005
- Registration date
- 25/07/2005
- Last edited
- 21/12/2011
- 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 Paul Aveyard
Scientific
Scientific
Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 8529 |
|---|---|
| p.n.aveyard@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nortriptyline and nicotine replacement therapy (NRT) |
| Primary outcome measure(s) |
Six months of continuous abstinence biochemically confirmed. |
| Key secondary outcome measure(s) |
1. Seven-day point prevalence |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 31/05/2008 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
