Nicotine nasal spray for smoking cessation in primary care
ISRCTN | ISRCTN03150596 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN03150596 |
Secondary identifying numbers | 9820384; G7804283 |
- Submission date
- 12/03/2010
- Registration date
- 15/04/2010
- Last edited
- 08/08/2011
- 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
Mr John Stapleton
Scientific
Scientific
Institute Of Psychiatry
Kings College London
Postal Box P075
4 Windsor Walk
London
SE5 8AF
United Kingdom
j.stapleton@iop.kcl.ac.uk |
Study information
Study design | Multicentre randomised placebo controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Randomised placebo controlled trial of nicotine nasal spray for smoking cessation in primary care |
Study acronym | GPNNS |
Study objectives | To compare the effectiveness of nicotine nasal spray and placebo when given with brief GP and nurse support in primary care. |
Ethics approval(s) | King's Lynn Medical Research Ethics Committee approved on the 21st November 1995 (ref: 95-NNNS-014 (34/95)) |
Health condition(s) or problem(s) studied | Tobacco dependence |
Intervention | Active or placebo nicotine nasal spray for 12 weeks plus brief primary care counseling support. Total duration of follow-up is 12 weeks. |
Intervention type | Other |
Primary outcome measure | Co-verified complete abstinence from smoking for weeks 3 to 12. |
Secondary outcome measures | 1. Co-verified complete abstinence from smoking during 12 weeks 2. Adverse events |
Overall study start date | 01/02/1996 |
Completion date | 01/02/1999 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 1200 |
Key inclusion criteria | 1. Smokers: smoking for at least 3 years 2. Aged 20 - 60 years, either sex 3. Smokes 15 or more cigarettes a day 4. Motivated to stop |
Key exclusion criteria | 1. Myocardial infarction within 3 years 2. Chronic nasal disorder 3. Pregnancy, intending pregnancy 4. Breast feeding 5. Current psychiatric care 6. Current use of psychotropic drugs |
Date of first enrolment | 01/02/1996 |
Date of final enrolment | 01/02/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute Of Psychiatry
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
McNeil AB (Sweden) - formally Pharmacia and Upjohn
Industry
Industry
Box 941
Helsingborg
251 09
Sweden
GGustavs@its.jnj.com | |
Website | http://www.mcneilab.se/contact |
https://ror.org/020jwmq86 |
Funders
Funder type
Research council
Kings College London (UK) - Institute of Psychiatry, staff supported by MRC Programme Grant (ref: G7804283)
No information available
McNeil AB (Sweden) - formally Pharmacia and Upjohn, supported trial costs
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/04/2011 | Yes | No |