Contact information
Type
Scientific
Primary contact
Mr John Stapleton
ORCID ID
Contact details
Institute Of Psychiatry
Kings College London
Postal Box P075
4 Windsor Walk
London
SE5 8AF
United Kingdom
j.stapleton@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9820384; G7804283
Study information
Scientific title
Randomised placebo controlled trial of nicotine nasal spray for smoking cessation in primary care
Acronym
GPNNS
Study hypothesis
To compare the effectiveness of nicotine nasal spray and placebo when given with brief GP and nurse support in primary care.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/02/1996
Overall trial end date
01/02/1999
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1200
Participant 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
Recruitment start date
01/02/1996
Recruitment end date
01/02/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute Of Psychiatry
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
McNeil AB (Sweden) - formally Pharmacia and Upjohn
Sponsor details
Box 941
Helsingborg
251 09
Sweden
GGustavs@its.jnj.com
Sponsor type
Industry
Website
Funders
Funder type
Research council
Funder name
Kings College London (UK) - Institute of Psychiatry, staff supported by MRC Programme Grant (ref: G7804283)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
McNeil AB (Sweden) - formally Pharmacia and Upjohn, supported trial costs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21205043
Publication citations
-
Results
Stapleton JA, Sutherland G, Treating heavy smokers in primary care with the nicotine nasal spray: randomized placebo-controlled trial., Addiction, 2011, 106, 4, 824-832, doi: 10.1111/j.1360-0443.2010.03274.x.