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Nicotine nasal spray for smoking cessation in primary care
ISRCTN ISRCTN03150596
DOI 10.1186/ISRCTN03150596
ClinicalTrials.gov identifier
EudraCT number
Public title Nicotine nasal spray for smoking cessation in primary care
Scientific title Randomised placebo controlled trial of nicotine nasal spray for smoking cessation in primary care
Acronym GPNNS
Serial number at source 9820384; G7804283
Study hypothesis To compare the effectiveness of nicotine nasal spray and placebo when given with brief GP and nurse support in primary care.
Lay summary Not provided at time of registration
Ethics approval King's Lynn Medical Research Ethics Committee approved on the 21st November 1995 (ref: 95-NNNS-014 (34/95))
Study design Multicentre randomised placebo controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Tobacco dependence
Participants - 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
Participants - 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
Anticipated start date 01/02/1996
Anticipated end date 01/02/1999
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1200
Interventions Active or placebo nicotine nasal spray for 12 weeks plus brief primary care counseling support. Total duration of follow-up is 12 weeks.
Primary outcome measure(s) Co-verified complete abstinence from smoking for weeks 3 to 12.
Secondary outcome measure(s) 1. Co-verified complete abstinence from smoking during 12 weeks
2. Adverse events
Sources of funding 1. Kings College London (UK) - Institute of Psychiatry, staff supported by MRC Programme Grant (ref: G7804283)
2. McNeil AB (Sweden) - formally Pharmacia and Upjohn, supported trial costs
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21205043
Contact name Mr  John  Stapleton
  Address Institute Of Psychiatry
Kings College London
Postal Box P075
4 Windsor Walk
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Email j.stapleton@iop.kcl.ac.uk
Sponsor McNeil AB (Sweden) - formally Pharmacia and Upjohn
  Address Box 941
  City/town Helsingborg
  Zip/Postcode 251 09
  Country Sweden
  Email GGustavs@its.jnj.com
  Sponsor website: http://www.mcneilab.se/contact
Date applied 12/03/2010
Last edited 08/08/2011
Date ISRCTN assigned 15/04/2010
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