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

Institute Of Psychiatry
Kings College London
Postal Box P075
4 Windsor Walk
London
SE5 8AF
United Kingdom

Email j.stapleton@iop.kcl.ac.uk

Study information

Study designMulticentre randomised placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised placebo controlled trial of nicotine nasal spray for smoking cessation in primary care
Study acronymGPNNS
Study objectivesTo 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) studiedTobacco dependence
InterventionActive or placebo nicotine nasal spray for 12 weeks plus brief primary care counseling support. Total duration of follow-up is 12 weeks.
Intervention typeOther
Primary outcome measureCo-verified complete abstinence from smoking for weeks 3 to 12.
Secondary outcome measures1. Co-verified complete abstinence from smoking during 12 weeks
2. Adverse events
Overall study start date01/02/1996
Completion date01/02/1999

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants1200
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/1996
Date of final enrolment01/02/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute Of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

McNeil AB (Sweden) - formally Pharmacia and Upjohn
Industry

Box 941
Helsingborg
251 09
Sweden

Email GGustavs@its.jnj.com
Website http://www.mcneilab.se/contact
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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