Additional identifiers
EudraCT number
2008-006433-28
ClinicalTrials.gov number
Protocol/serial number
RG_08_082
Study information
Scientific title
Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial
Acronym
Study hypothesis
The 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
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
Study design
Randomised controlled unblinded non-inferiority trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Smoking cessation in response to nicotine addiction
Intervention
Participants 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 type
Drug
Phase
Not Applicable
Drug names
Nicotine (Niquitin, Nicotinell, Nicorette)
Primary outcome measures
Abstinence 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 measures
Point 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 trial start date
01/10/2008
Overall trial end date
17/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Participants 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
686 (343 participants in each arm).
Participant exclusion criteria
Pregnancy will be the only exclusion for insurance purposes
Recruitment start date
26/06/2009
Recruitment end date
13/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
c/o Brian Berry
Research and Enterprise Services
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK) (ref: PG/08/047/25082)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
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
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19682359
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26975007
Publication citations
-
Protocol
Lindson N, Aveyard P, Ingram JT, Inglis J, Beach J, West R, Michie S, Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial., Trials, 2009, 10, 69, doi: 10.1186/1745-6215-10-69.
-
Results
Lindson-Hawley N, Banting M, West R, Michie S, Shinkins B, Aveyard P, Gradual Versus Abrupt Smoking Cessation: A Randomized, Controlled Noninferiority Trial, Ann Intern Med, 2016, doi: 10.7326/M14-2805.