Nicotine nasal spray for smoking cessation in primary care

ISRCTN	ISRCTN03150596
DOI	https://doi.org/10.1186/ISRCTN03150596
Protocol serial number	9820384; G7804283
Sponsor	McNeil AB (Sweden) - formally Pharmacia and Upjohn
Funders	Kings College London (UK) - Institute of Psychiatry, staff supported by MRC Programme Grant (ref: G7804283), McNeil AB (Sweden) - formally Pharmacia and Upjohn, supported trial costs

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Multicentre randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Co-verified complete abstinence from smoking for weeks 3 to 12.
Key secondary outcome measure(s)	1. Co-verified complete abstinence from smoking during 12 weeks 2. Adverse events
Completion date	01/02/1999

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Institute Of Psychiatry

London
SE5 8AF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes