Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial.
BACKGROUND
The standard way to stop smoking is to stop abruptly on a quit day with no prior reduction in consumption of cigarettes. Many smokers feel that reduction is natural and if reduction programmes were offered, many more might take up treatment. Few trials of reduction versus abrupt cessation have been completed. Most are small, do not use pharmacotherapy, and do not meet the standards necessary to obtain a marketing authorization for a pharmacotherapy.


METHODS
We will conduct a non-inferiority randomised trial of rapid reduction versus standard abrupt cessation among smokers who want to stop smoking. In the reduction arm, participants will be advised to reduce smoking consumption by half in the first week and to 25% of baseline in the second, leading up to a quit day at which participants will stop smoking completely. This will be assisted by nicotine patches and an acute form of nicotine replacement therapy. In the abrupt arm participants will use nicotine patches only, whilst smoking as normal, for two weeks prior to a quit day, at which they will also stop smoking completely. Smokers in either arm will have standard withdrawal orientated behavioural support programme with a combination of nicotine patches and acute nicotine replacement therapy post-cessation. OUTCOMES/FOLLOW-UP: The primary outcome of interest will be prolonged abstinence from smoking, with secondary trial outcomes of point prevalence, urges to smoke and withdrawal symptoms. Follow up will take place at 4 weeks, 8 weeks and 6 months post-quit day.


BACKGROUND
Current Controlled Trials ISRCTN22526020.
Lindson
Nicola
N
Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK. nll839@bham.ac.uk
Aveyard
Paul
P
Ingram
Jackie T
JT
Inglis
Jennie
J
Beach
Jane
J
West
Robert
R
Michie
Susan
S
D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012107:Research Design; D012449:Safety; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology
Addiction. 2001 Jun;96(6):891-902
11399220
Thorax. 2007 Oct;62(10):898-903
17483139
J Consult Clin Psychol. 1995 Jun;63(3):388-99
7608351
Nicotine Tob Res. 2007 Nov;9(11):1177-82
17978992
Nicotine Tob Res. 2006 Dec;8(6):739-49
17132521
Addiction. 2008 Apr;103(4):557-63
18339101
JAMA. 1998 Jul 8;280(2):152-6
9669788
Lancet. 1992 Aug 8;340(8815):324-9
1353803
Nicotine Tob Res. 2003 Feb;5(1):13-25
12745503
JAMA. 2006 Mar 8;295(10):1152-60
16522836
Addiction. 2007 Aug;102(8):1326-7
17624983
Addict Behav. 2007 May;32(5):912-23
16875787
Health Technol Assess. 2008 Feb;12(2):iii-iv, ix-xi, 1-135
18093448
Nicotine Tob Res. 2007 Jun;9(6):671-5
17558824
Addiction. 2005 Mar;100(3):299-303
15733243
Stat Methods Med Res. 1998 Jun;7(2):187-203
9654641
JAMA. 1988 Sep 16;260(11):1593-6
3411739
Eur Respir J. 1999 Feb;13(2):238-46
10065662
Drug Alcohol Depend. 1992 Feb;29(3):231-6
1559428
J Consult Clin Psychol. 1971 Apr;36(2):153-62
5550982
Addiction. 2005 Apr;100 Suppl 2:59-69
15755262
Nicotine Tob Res. 2007 Aug;9(8):801-10
17654293
Br J Addict. 1989 Jun;84(6):591-8
2752191
Br J Addict. 1991 Sep;86(9):1119-27
1932883
Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9
15179542
Cochrane Database Syst Rev. 2007 Jan 24;(1):CD006103
17253581
Addiction. 2007 May;102(5):809-14
17493108
Addiction. 2004 Jan;99(1):29-38
14678060
Prev Med. 2007 Mar;44(3):230-4
17207524
Nicotine Tob Res. 2004 Apr;6(2):327-48
15203807
Chest. 1995 Aug;108(2):447-51
7634882
Addiction. 2007 Apr;102(4):506-9
17362283
Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000146
18253970
Nicotine Tob Res. 2004 Apr;6(2):377-9
15203811
Addiction. 2007 Jul;102(7):1158-63
17567405
Nicotine Tob Res. 2002;4 Suppl 2:S73-9
12573169
Health Educ Q. 1988 Summer;15(2):199-216
3378904
Tob Control. 2006 Aug;15(4):280-5
16885576
Arch Intern Med. 1991 Oct;151(10):1993-8
1929687