Rapid reduction versus abrupt quitting for smokers who want to stop soon

ISRCTN ISRCTN22526020
DOI https://doi.org/10.1186/ISRCTN22526020
EudraCT/CTIS number 2008-006433-28
Secondary identifying numbers RG_08_082
Submission date
14/10/2008
Registration date
22/10/2008
Last edited
16/03/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Aveyard
Scientific

Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Study information

Study designRandomised controlled unblinded non-inferiority trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial
Study objectivesThe trial will investigate the abstinence success rates of participants reducing cigarette smoking by 50% for two weeks prior to smoking quit date whilst using nicotine replacement therapy (NRT), when compared with abrupt cessation with no cutting down, whilst also utilising NRT for two weeks prior to quitting.
Ethics approval(s)1. Nottingham Research Ethics Committee 2, 20/01/2009, ref: 08/H0408/213
2. Medicines and Healthcare products Regulatory Agency (MHRA), 12/12/2008, ref: 21761/0222/001-0001
Health condition(s) or problem(s) studiedSmoking cessation in response to nicotine addiction
InterventionParticipants will be seen at an assessment session, similar to that used by the stop smoking services. Here they will be randomised 1:1 to reduction or abrupt cessation arm of the trial.

In the rapid reduction arm participants will decide on a quit date in two weeks time, and in the two weeks leading up to this will reduce smoking consumption by 50%, whilst using nicotine patches (Niquitin, Nicotinell, Nicorette), usually 21 mg, and replacing missing cigarettes with an acute form of nicotine replacement therapy (for example nicotine gum). Participants will be asked to complete a daily diary (explained at the assessment visit). The target number of cigarettes will be completed for each day, and at the end of each day participants will be asked to put aside the next day's cigarettes into a separate pack to encourage adherence to target.

In the abrupt cessation arm participants will also decide on a quit date in two weeks time and be given homework to identify critical cigarettes, which will be the basis for the pre-quit discussion the next week. During the two-week period leading up to the quit date participants will also use patches (usually 21 mg), but will not utilise acute NRT.

Both arms will then go on to have five weekly sessions on quit week and weekly thereafter, following the typical seven-session UK withdrawal-orientated therapy programme. Follow-up will also be carried out eight weeks and six months after quit day. All NRT used will have the brand name Niquitin, Nicotinell or Nicorette, and participants will be able to have some input in the type(s) of NRT and dosage that they use.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Nicotine (Niquitin, Nicotinell, Nicorette)
Primary outcome measureAbstinence at four weeks in all treatment arms, measured according to the Russell standard (allows a two-week grace period from quit day for slips).
Secondary outcome measuresPoint prevalence at each follow-up and prolonged abstinence at eight weeks and six months (according to the Russell standard). Throughout the trial and at follow-up, the following will be monitored:
1. Urges and withdrawal (using the Mood and Physical Symptoms Scale [MPSS])
2. Self-efficacy
3. Exhaled carbon monoxide (using a CO monitor)
4. Salivary continine levels
5. Daily smoking and NRT use (using written diaries)
6. Satisfaction from smoking particular cigarettes (using the Cigarette Evaluation Scale)
Overall study start date01/10/2008
Completion date17/09/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants686 (343 participants in each arm).
Key inclusion criteriaParticipants will be recruited by writing to patients on GP practice lists recorded as smokers, writing to people on the stop smoking service's database who have tried and failed to stop, and by offering the treatment to those booking with the stop smoking service. Any participants will be eligible if they are:
1. Prepared to stop either abruptly in two weeks or cut down and stop over two weeks
2. Aged 18 or over, either sex
3. Willing and able to complete data collection
Key exclusion criteriaPregnancy will be the only exclusion for insurance purposes
Date of first enrolment26/06/2009
Date of final enrolment13/12/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

c/o Brian Berry
Research and Enterprise Services
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website http://www.bham.ac.uk/
ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Charity

British Heart Foundation (BHF) (UK) (ref: PG/08/047/25082)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
the_bhf, The British Heart Foundation, BHF
Location
United Kingdom

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?
Protocol article protocol 14/08/2009 Yes No
Results article results 03/05/2016 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

16/03/2016: Publication reference added.

On 04/12/2014 the overall trial end date was changed from 01/10/2011 to 17/09/2012.