Condition category
Mental and Behavioural Disorders
Date applied
12/03/2010
Date assigned
15/04/2010
Last edited
08/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.mcneilab.se/contact

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21205043

Publication citations

  1. 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.

Additional files

Editorial Notes