ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

Lifestyle

Intervention code [2]

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]

The proportion of participants who report 7-day point prevalence abstinence at six months since Quit date (biochemically verified)

Timepoint [1]

6 months post quit date

Secondary outcome [1]

Three week, six week and three month 7-day point prevalence abstinence rates since quit date.

Timepoint [1]

three weeks, six weeks and three months since quit date.

Secondary outcome [2]

Three and six month continuous abstinence rates since quit date, biochemically verified at 6 months

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/04/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

1410

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council NZ

Address [1]

PO Box 5541, Wellesley Street, Auckland, 1141, New Zealand

Country [1]

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]

University

Name [1]

Clinical Trials Research Unit

Address [1]

CTRU, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142

Country [1]

New Zealand

Other collaborator category [1]

University

Name [1]

Auckland Tobacco Control Research Group

Address [1]

School of Population Health, University of Auckland, Private Bag 92019, Auckland

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Multi-region Ethics Committee

Ethics committee address [1]

Ministry of Health
2nd Floor, 1-3 The Terrace
PO Box 5013, Wellington

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/09/2008

Approval date [1]

03/11/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Colin Howe

Address

CTRU, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142

Country

New Zealand

Phone

+64 9 373 7599

Fax

+64 9 373 1710

c.howe@ctru.auckland.ac.nz

Contact person for scientific queries

Name

Dr Natalie Walker

Address

CTRU, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142

Country

New Zealand

Phone

+64 9 373 7599

Fax

+64 9 373 1710

c.howe@nihi.auckland.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	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	2011	https://doi.org/10.1186/1471-2458-11-37

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically