A randomised, controlled trial in primary care of a nicotine replacement therapy (NRT) assisted cessation intervention amongst adult smokers with established vascular disease to confirm effectiveness, safety and genetic influences
| ISRCTN | ISRCTN27140757 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27140757 |
| Protocol serial number | N/A |
| Sponsor | University of Oxford (UK) |
| Funder | Medical Research Council (MRC) (Grant number: G0200247) |
- Submission date
- 19/01/2005
- Registration date
- 01/04/2005
- Last edited
- 03/03/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul Aveyard
Scientific
Scientific
General Practice Research Group
Department of Clinical Pharmacology
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 2BE
United Kingdom
| Phone | +44 (0)1865 228484 |
|---|---|
| paul.aveyard@clinpharm.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | RESCINDING |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | Nicotine replacement therapy in the form of patches versus placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 30/06/2008 |
| Reason abandoned (if study stopped) | TRIAL TERMINATED BEFORE RECRUITMENT started due to lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 2400 |
| Key inclusion criteria | All smokers (self-report ≥10 cigarettes per day) aged 18 years and over who wish to stop with (at least) one of the following diagnoses: 1. Ischaemic Heart Disease: i. Stable Angina, clinically or exercise electrocardiogram (ECG) diagnosed ii. Myocardial infarction more than 2 months previously with recovery uncomplicated by any rhythm disturbances other than atrial fibrillation 2. Cerebrovascular disease: No exclusions 3. Peripheral vascular disease: No exclusions |
| Key exclusion criteria | 1. Patients the GP, for whatever reason, does not wish to include 2. Known skin hypersensitivity to nicotine, plasters or widespread active eczema/psoriasis or other skin conditions that would restrict patch application 3. Pregnant or breast feeding women or those who are not using reliable contraceptive methods 4. Phaeochromocytoma/Hyperthyroidism and severe renal and/or hepatic impairment 5. Severe (life threatening) arrhythmia 6. Command of English (+/- interpreter) or impairment of faculties does not allow informed consent |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
General Practice Research Group
Oxford
OX2 2BE
United Kingdom
OX2 2BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
