Condition category
Mental and Behavioural Disorders
Date applied
14/10/2008
Date assigned
22/10/2008
Last edited
16/03/2016
Prospective/Retrospective
Prospectively 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

Dr Paul Aveyard

ORCID ID

Contact details

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

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

http://www.bham.ac.uk/

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

  1. 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.

  2. 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.

Additional files

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.