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

ISRCTN	ISRCTN22526020
DOI	https://doi.org/10.1186/ISRCTN22526020
Clinical Trials Information System (CTIS)	2008-006433-28
Protocol serial number	RG_08_082
Sponsor	University of Birmingham (UK)
Funder	British Heart Foundation (BHF) (UK) (ref: PG/08/047/25082)

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

Primary study design	Interventional
Study design	Randomised controlled unblinded non-inferiority trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	Nicotine (Niquitin, Nicotinell, Nicorette)
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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)
Completion date	17/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	686
Key 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
Key exclusion criteria	Pregnancy will be the only exclusion for insurance purposes
Date of first enrolment	26/06/2009
Date of final enrolment	13/12/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/05/2016		Yes	No
Protocol article	protocol	14/08/2009		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.