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Trial registered on ANZCTR


Registration number
ACTRN12608000410358
Ethics application status
Approved
Date submitted
21/08/2008
Date registered
21/08/2008
Date last updated
8/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
RELIQ Study: Reduced levels of nicotine in cigarettes to increase quitting
Scientific title
A single-blind randomised controlled trial of nicotine-free cigarettes as an adjunct to usual nicotine replacement therapy (NRT)-based cessation practice (patch, gum and/or lozenge), in people who wish to stop smoking.
Secondary ID [1] 273456 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
RELIQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 3583 0
Condition category
Condition code
Public Health 3743 3743 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Nicotine replacement therapy (NRT) (eg patches and or gum or lozenges) as directed by smoking cessation adviser and reduced nicotine cigarettes (containing<= 0.05 mg nicotine per cigarette)
2. Duration of 6 weeks for nicotine free cigarettes (as required, eg 800 cigarettes) and 8 weeks for the NRT given concurrently.
Intervention code [1] 3299 0
Lifestyle
Intervention code [2] 3305 0
Behaviour
Comparator / control treatment
Usual practice with NRT (eg patches: with 21mg, 14mg or 7 mg nicotine , gum (fruit or mint): 4mg or 2mg nicotine or lozenge 2mg or 1mg nicotine) as directed by a smoking cessation advisor for 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 4642 0
The proportion of participants who report 7-day point prevalence abstinence at six months since Quit date (biochemically verified)
Timepoint [1] 4642 0
6 months post quit date
Secondary outcome [1] 7849 0
Three week, six week and three month 7-day point prevalence abstinence rates since quit date.
Timepoint [1] 7849 0
three weeks, six weeks and three months since quit date.
Secondary outcome [2] 7850 0
Three and six month continuous abstinence rates since quit date, biochemically verified at 6 months
Timepoint [2] 7850 0
Three and six months since quit date

Eligibility
Key inclusion criteria
1. they want to stop smoking
2. they are at least 18 years of age
3. their time to first cigarette is within 30 minutes of waking
4. they are able to provide verbal consent
5. they have access to a telephone
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant and breastfeeding women and smokers who have had a heart attack, stroke, or unstable angina within the last two weeks will be excluded, as will smokers who are current users of NRT products, those who use only non-cigarette tobacco products (e.g. pipes, cigars), those who are currently using non nicotine-based cessation therapies (e.g. buproprion [Zyban], clonidine, nortriptyline, or varenicline [Champix]), and those who are current clients of Txt2Quit and NRT Online.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by age gender and level of smoking dependency are used for the stratification via computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1170 0
New Zealand
State/province [1] 1170 0

Funding & Sponsors
Funding source category [1] 3759 0
Government body
Name [1] 3759 0
Health Research Council NZ
Address [1] 3759 0
PO Box 5541, Wellesley Street, Auckland, 1141, New Zealand
Country [1] 3759 0
New Zealand
Primary sponsor type
Government body
Name
Heath Research Council NZ
Address
PO Box 5541, Wellesley Street, Auckland, 1141, New Zealand
Country
New Zealand
Secondary sponsor category [1] 3374 0
University
Name [1] 3374 0
Clinical Trials Research Unit
Address [1] 3374 0
CTRU, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country [1] 3374 0
New Zealand
Other collaborator category [1] 377 0
University
Name [1] 377 0
Auckland Tobacco Control Research Group
Address [1] 377 0
School of Population Health, University of Auckland, Private Bag 92019, Auckland
Country [1] 377 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5825 0
Multi-region Ethics Committee
Ethics committee address [1] 5825 0
Ministry of Health
2nd Floor, 1-3 The Terrace
PO Box 5013, Wellington
Ethics committee country [1] 5825 0
New Zealand
Date submitted for ethics approval [1] 5825 0
01/09/2008
Approval date [1] 5825 0
03/11/2008
Ethics approval number [1] 5825 0
MEC/08/10/117

Summary
Brief summary
Smoking is the leading cause of lost healthy life years in New Zealand. Although smoking prevalence has been slowly declining in recent years (2002/3: 23% in adults, 2006/7: 19% in adults4), it remains particularly high in Maori (2007: 40% Maori women, 35% Maori men) and additional options for smokers who want to quit are needed. Although a variety of methods are available to help people stop smoking, many of them are expensive, have side effects, and despite their use most quit attempts still fail. There is some evidence that progressive reduction in the level of nicotine in cigarette tobacco can reduce the level of nicotine dependence in smokers, without any compensatory smoking9. Furthermore, evidence suggests that the use of NRT in combination with nicotine-free cigarettes may have an impact on the signs and symptoms of withdrawal and cessation rates.

The proposed trial will test the balance of benefits and risks of a new strategy for people to overcome nicotine addiction, namely the combined use of nicotine-free cigarettes and NRT immediately after quitting. If the study confirms that the intervention in question is an effective time-limited smoking cessation strategy, then further research can be undertaken to determine the implications of these research findings on current policy and practice. If proven safe and effective this strategy is likely to have substantial public health benefits.
Trial website
https://www.ctru.auckland.ac.nz/smokingiq
Trial related presentations / publications
Walker N, Bullen C, McRobbie H. Reduced-nicotine content cigarettes: Is there potential to aid smoking cessation? Nicotine & Tobacco Research 2009; doi: 10.1093/ntr/ntp147.
Walker N, Howe C, Bullen C, Grigg M, Glover M, McRobbie H, Laugesen M, Vander Hoorn S, Whittaker R. Study protocol for a randomised trial of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice in people who wish to stop smoking. BMC Public Health 2011 11:37: doi:10.1186/1471-2458-11-37. http://www.biomedcentral.com/1471-2458/11/37
Walker N, Howe, C, Bullen, C, Grigg, M, Glover, M, McRobbie, H, Laugesen, M, Parag V, Whittaker, R. ‘Can the use of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice help people quit smoking? Findings from a randomised trial.’ [Rapid response poster]. Society for Research on Nicotine and Tobacco Europe 13th Annual Meeting, Antalya, Turkey. 8-11 September 2011.
Walker N, Howe C, Bullen C, Grigg M, Glover M, McRobbie H, Laugesen M, Parag V, Whittaker R. The effect of very low nicotine content cigarettes, used as an adjunct to nicotine replacement therapy, on smoking cessation: a randomised controlled trial. Addiction 2012 [submitted November 2011]
Walker N, Howe, C, Bullen, C, Grigg, M, Glover, M, McRobbie, H, Laugesen, M, Parag V, Whittaker, R. ‘Can the use of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice help people quit smoking? Findings from a randomised trial.’ Society for Research on Nicotine and Tobacco Europe 13th Annual Meeting, Antalya, Turkey. 8-11 September 2011.[poster].
Walker N, Bullen C, McRobbie H. Reduced nicotine cigarettes as an aid to smoking cessation. Nicotine and Tobacco Research 2009; 11 (11): 1274 - 1279. Epub 2009 Sep 30.
Walker N, Howe C, Bullen C, Grigg M, Glover M, McRobbie H, Laugesen M, Vander Hoorn S, Whittaker R, Rodgers A. The study protocol for a randomised trial of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice, in people who wish to stop smoking. BMC Public Health 2011 11:37: doi:10.1186/1471-2458-11-37.[Highly accessed]
Walker N, Howe, C, Bullen, C, Grigg, M, Glover, M, McRobbie, H, Laugesen, M, Jiang, J, Whittaker, R. ‘Hazardous drinking and alcohol dependence in callers to the New Zealand Quitline: Findings from a randomised trial.’ [poster]. Society for Research on Nicotine and Tobacco 18th Annual Meeting, Houston, USA. 13-16 March 2012.
Walker N, Howe, C, Bullen, C, Grigg, M, Glover, M, McRobbie, H, Laugesen, M, Parag V, Whittaker, R. ‘The effect of history of hazardous drinking and alcohol dependence on smoking cessation: Findings from a randomised trial.’ [poster]. Society for Research on Nicotine and Tobacco 18th Annual Meeting, Houston, USA. 13-16 March 2012.
Walker N, Howe C, Bullen C, Grigg M, Glover M, McRobbie H, Laugesen M, Parag V, Whittaker R. The combined effect of very low nicotine content cigarettes, used as an adjunct to usual Quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: A randomised controlled trial. Addiction 2012: Accepted manuscript online: 30 MAR 2012 12:14PM EST | DOI: 10.1111/j.1360-0443.2012.03906.x
Public notes

Contacts
Principal investigator
Name 28864 0
Address 28864 0
Country 28864 0
Phone 28864 0
Fax 28864 0
Email 28864 0
Contact person for public queries
Name 12021 0
Dr Colin Howe
Address 12021 0
CTRU, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 12021 0
New Zealand
Phone 12021 0
+64 9 373 7599
Fax 12021 0
+64 9 373 1710
Email 12021 0
c.howe@ctru.auckland.ac.nz
Contact person for scientific queries
Name 2949 0
Dr Natalie Walker
Address 2949 0
CTRU, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 2949 0
New Zealand
Phone 2949 0
+64 9 373 7599
Fax 2949 0
+64 9 373 1710
Email 2949 0
c.howe@nihi.auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary