Randomised comparison of nicotine replacement therapy and bupropion in the treatment of tobacco dependence

ISRCTN ISRCTN91464711
DOI https://doi.org/10.1186/ISRCTN91464711
Secondary identifying numbers G0200455
Submission date
06/08/2003
Registration date
07/08/2003
Last edited
06/05/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
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

Phone +44 (0)20 7848 0450
Email j.stapleton@iop.kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymZORN
Study objectivesTo compare effectiveness of the three treatments in routine National Health Service (NHS) care.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedTobacco dependence
InterventionGroup and individual specialist counselling over six weeks, plus NRT, bupropion or both
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bupropion
Primary outcome measureSmoking status at four weeks and 12 months
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2004
Completion date30/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants1800
Key inclusion criteriaAll smokers eligible to use Nicotine Replacement Therapy (NRT) and bupropion who present for help to stop smoking
Key exclusion criteriaThose with contraindications for NRT or bupropion
Date of first enrolment01/05/2004
Date of final enrolment30/06/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute Of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Website http://www.iop.kcl.ac.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Government

Department of Health (UK)

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 01/12/2013 Yes No