Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Sex
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
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] 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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
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
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIStudy protocol for a randomised trial of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice, in people who wish to stop smoking2011https://doi.org/10.1186/1471-2458-11-37
N.B. These documents automatically identified may not have been verified by the study sponsor.