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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 7860 0
7005 - University Of Tasmania
Recruitment postcode(s) [2] 10692 0
7001 - Hobart

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
Address [1] 288866 0
Pfizer,
235 East 42nd Street
NY, NY 10017
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
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