Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000329662
Ethics application status
Approved
Date submitted
12/03/2014
Date registered
27/03/2014
Date last updated
26/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Examination of mechanism of action of pre-quit use of nicotine patch and varenicline for smoking cessation
Scientific title
Effect of treatment with pre-quit nicotine patch or pre-quit varenicline or standard nicotine patch for regular daily smokers aged over 18 on abstinence at four weeks
Secondary ID [1] 284238 0
none
Universal Trial Number (UTN)
Trial acronym
PQT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
smoking cessation 291350 0
Condition category
Condition code
Public Health 291714 291714 0 0
Health promotion/education
Mental Health 291803 291803 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Varenicline 6 weeks, including 2 weeks prior to a set quit date; oral dose 0.5 mg once daily for 3 days, 0.5 mg twice daily for 4 days, 1 mg twice daily for weeks 2-6.
or
Nicotine patch 21mg/24 hours 6 weeks, including 2 weeks prior to a set quit date.
Daily monitoring adherence via participant study phone device
Intervention code [1] 288946 0
Treatment: Drugs
Comparator / control treatment
Nicotine patch 21mg/24 hours 4 weeks commencing on a set quit date
Control group
Active

Outcomes
Primary outcome [1] 291655 0
Smoking reduction (cigarettes per day) from daily log of cigarettes on study smartphone device
Timepoint [1] 291655 0
During 2 weeks prior to quit date
Primary outcome [2] 291656 0
Cigarette craving via visual analogue scale on study smartphone device
Timepoint [2] 291656 0
During 2 weeks prior to quit date at random daily time points and at selected logged cigarettes each day.
Primary outcome [3] 291657 0
Satisfaction with cigarette smoking via visual analogue scale on study smartphone device
Timepoint [3] 291657 0
During 2 weeks prior to quit date at random daily time points and at selected logged cigarettes each day.
Secondary outcome [1] 307241 0
Biochemically-verified abstinence from smoking using Carbon monoxide in expired air
Timepoint [1] 307241 0
28 days post quit date

Eligibility
Key inclusion criteria
a) greater than or equal to 18 years old; b) smoke greater than or equal to 15 cigarettes per day for the past three years; c) have high motivation to quit smoking (75/100); d) be willing and able to use either patches or varenicline as part of a quit attempt.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) are currently enrolled in a smoking cessation trial, or have been within the past three months; b) are unsuitable for treatment with either patches or varenicline (per prescribing guidelines).

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)
Sequential allocation to allocation sequence pre-prepared by third party
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to study groups using a computer generated block randomisation scheme.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cigarette craving and smoking satisfaction will be used to predict smoking reduction using multilevel structural equation models, with treatment group included as a variable. Smoking reduction during the pre-quit phase will be used in a logistic regression model to predict 4 week abstinence with treatment group as a covariate. Abstinence analysis will be conducted as intent-to-treat, dropouts will be counted as treatment failures.
The proposed sample size (n=216; 72 participants per group) was determined by the requirements of the primary research questions – detecting reductions in satisfaction (H1) and craving (H2) scores, and smoking rate (H3), between the SP and the two pre-quit treatment groups (PQP and VAR) at the end of the pre-quit treatment period (Visit 3). In a pilot study we observed moderate-to-large effects of pre-quit patch treatment on self-reported satisfaction with smoking, craving, and smoking rate during the pre-quit treatment period. Using these reductions as a proxy for between-group differences (assuming that these measures will not decrease during the pre-quit period for participants in the SP group), a conservative estimate of within-subject correlation of measures (0.5), our proposed sample will afford >90% power to detect a difference in these measures. Our proposed sample size will also afford >80% power to detect an effect of smoking reduction during the pre-quit phase on treatment outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/03/2014
Actual
27/03/2014
Date of last participant enrolment
Anticipated
27/11/2015
Actual
19/05/2016
Date of last data collection
Anticipated
Actual
20/07/2016
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 10692 0
7001 - Hobart
Recruitment postcode(s) [2] 7860 0
7005 - University Of Tasmania

Funding & Sponsors
Funding source category [1] 288866 0
Commercial sector/Industry
Name [1] 288866 0
Global Research Awards for Nicotine Dependence (GRAND) Program 2013 funded by Pfizer
Country [1] 288866 0
United States of America
Primary sponsor type
Individual
Name
Dr Stuart Ferguson
Address
Private Bag 68, School of Medicine, University of Tasmania, Hobart, Tasmania, 7001
Country
Australia
Secondary sponsor category [1] 287562 0
None
Name [1] 287562 0
Address [1] 287562 0
Country [1] 287562 0
Other collaborator category [1] 277866 0
Individual
Name [1] 277866 0
Dr Julia Walters
Address [1] 277866 0
Private Bag 68, School of Medicine, University of Tasmania, Hobart, Tasmania, 7001
Country [1] 277866 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290695 0
Tasmania Health & Medical Human Research Ethics Committee
Ethics committee address [1] 290695 0
Office of Research Services, University of Tasmania,
Private Bag 1
Hobart
Tasmania 7001
Ethics committee country [1] 290695 0
Australia
Date submitted for ethics approval [1] 290695 0
Approval date [1] 290695 0
13/01/2014
Ethics approval number [1] 290695 0
H0013619

Summary
Brief summary
The primary objective of the proposed study is to test the mechanism of action of two pre-quit smoking cessation medications - varenicline and nicotine patch – in order to learn how best to optimize these pre-quit treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46846 0
Dr Stuart Ferguson
Address 46846 0
Private Bag 68, School of Medicine, University of Tasmania, Hobart TAS 7001
Country 46846 0
Australia
Phone 46846 0
+61 3 6226 4295
Fax 46846 0
Email 46846 0
Stuart.Ferguson@utas.edu.au
Contact person for public queries
Name 46847 0
Dr Stuart Ferguson
Address 46847 0
Private bag 68, University of Tasmania, Hobart TAS 7001
Country 46847 0
Australia
Phone 46847 0
+61 3 6226 1093
Fax 46847 0
Email 46847 0
bsrg.utas@gmail.com
Contact person for scientific queries
Name 46848 0
Dr Stuart Ferguson
Address 46848 0
Private Bag 68, School of Medicine, University of Tasmania, Hobart TAS 7001
Country 46848 0
Australia
Phone 46848 0
+61 3 6226 4295
Fax 46848 0
Email 46848 0
Stuart.Ferguson@utas.edu.au

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
EmbaseExamination of the mechanism of action of two pre-quit pharmacotherapies for smoking cessation.2015https://dx.doi.org/10.1186/s12889-015-2596-2
N.B. These documents automatically identified may not have been verified by the study sponsor.