Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001147774
Ethics application status
Approved
Date submitted
10/08/2022
Date registered
22/08/2022
Date last updated
12/04/2023
Date data sharing statement initially provided
22/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the long-term impact of nicotine replacement products on tobacco smoking cessation for low-socioeconomic status smokers
Scientific title
Investigating the long-term impact of nicotine replacement products on tobacco smoking cessation for low-socioeconomic status smokers
Secondary ID [1] 307681 0
APP105983
Universal Trial Number (UTN)
U1111-1281-6118
Trial acronym
Linked study record
Extended follow-up of ACTRN12621000076875

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 327219 0
Condition category
Condition code
Public Health 324355 324355 0 0
Health service research
Mental Health 324487 324487 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants of ACTRN12621000076875 were allocated a specific nicotine replacement product (vaporised nicotine product or oral nicotine replacement therapy [nicotine gum or lozenge]) at baseline.

This observational extended follow-up study investigates participants that successfully quit smoking (met trial primary outcome) in ACTRN12621000076875. Participants will be invited to take part/consent to the long-term follow-up study after their participation in ACTRN12621000076875 is complete (eg. 7-month interview and breath test completed).

This follow-up study involves a 15 minute telephone interview with a member of the research team at 19-months post baseline interview for ACTRN12621000076875. All participants will be asked to provide a salivary sample (collection kits sent and received via registered post) for analysis for presence of cotinine. The analysis will be completed by an independent laboratory in New South Wales, Australia. Participants that meet the self-reported abstinence outcome of less than or equal to 5 cigarettes in the 12-month period since their last interview (at the 19-month interview) will be asked to complete a carbon monoxide breath test. The breath test can be completed in-person or over a video call with a member of the research team.
Intervention code [1] 324155 0
Diagnosis / Prognosis
Comparator / control treatment
In ACTRN12621000076875, the participants allocated vaporised nicotine products were the intervention group and the participants allocated nicotine replacement therapy [nicotine gum or lozenge] were the control/comparator group. Participants from both groups are followed up in this observational study if they met the ACTRN12621000076875 primary outcome at final main trial follow-up (7-months from baseline).
Control group
Active

Outcomes
Primary outcome [1] 332157 0
Carbon monoxide (CO) verified 18-month continuous abstinence at 19-month follow-up. Continuous 18-month abstinence will be defined as having remained quit for 18-months (having smoked no more than five cigarettes in that time), and a carbon monoxide level of less-than-or-equal-to 5 parts per million. Depending on the participants indicated preference, the CO breath test will be self-administered using an using a hand-held iCO™ Smokerlyzer® (using provided instructions), or administered by a trained researcher using a hand-held iCO™ Micro+™ Smokerlyzer® with a disposable, one-use mouthpiece.
Timepoint [1] 332157 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [1] 412412 0
Carbon monoxide (CO) verified 12-month continuous abstinence at 19-month follow-up. Continuous 12-month abstinence will be defined as having remained quit for 12-months (having smoked no more than five cigarettes in that time), and a carbon monoxide level of less-than-or-equal-to 5 parts per million. Depending on the participants indicated preference, the CO breath test will be self-administered using an using a hand-held iCO™ Smokerlyzer® (using provided instructions), or administered by a trained researcher using a hand-held iCO™ Micro+™ Smokerlyzer® with a disposable, one-use mouthpiece.
Timepoint [1] 412412 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [2] 412413 0
Self-reported continuous abstinence: defined as self-report of smoking not more than five cigarettes at 19-month follow-up. The 19-month follow-up is a structured telephone interview conducted by a member of the research team.
Timepoint [2] 412413 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [3] 412414 0
Self-reported seven-day point prevalence abstinence: defined as self-report of having smoked no cigarettes (not even a puff) in the past seven days.
Timepoint [3] 412414 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [4] 412415 0
Cigarette consumption among re-lapsed smokers (Number of cigarettes smoked per day) at 19-month follow-up to assess maintenance use and dual use. The 19-month follow-up is a structured telephone interview conducted by a member of the research team.
Timepoint [4] 412415 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [5] 412416 0
Proportion of participants that re-lapsed to smoking (reported smoking in last 7 days) at 19-month follow-up. The 19-month follow-up is a structured telephone interview conducted by a member of the research team.
Timepoint [5] 412416 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [6] 412422 0
Proportion of participants that recovered from a smoking lapse (reported smoking more than 5 cigarettes in last 18-months but not smoking in last 7 days) at 19-month follow-up. The 19-month follow-up is a structured telephone interview conducted by a member of the research team.
Timepoint [6] 412422 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [7] 412423 0
Proportion of participants that had maintained nicotine replacement product use at 19-month follow-up interview. The 19-month follow-up is a structured telephone interview conducted by a member of the research team.
Timepoint [7] 412423 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [8] 412752 0
Change in tobacco withdrawal symptoms measured by responses about tobacco withdrawal symptoms using the Mood and Physical Symptoms Scale.
Timepoint [8] 412752 0
This outcome will use data from the baseline and 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.
Secondary outcome [9] 412753 0
Change in financial stress, assessed using the Index of Financial Stress.
Timepoint [9] 412753 0
This outcome will use data from the baseline and 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.
Secondary outcome [10] 412754 0
Change in respiratory symptoms measured by responses about respiratory symptoms using the Lower Respiratory Tract Infections-Visual Analogue Scale (LRTI-VAS) scale.
Timepoint [10] 412754 0
This outcome will use data from the baseline, check-in calls and 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.
Secondary outcome [11] 413169 0
Change in respiratory symptoms measured by responses about respiratory symptoms using the Modified Medical Research Council dyspnoea scale.
Timepoint [11] 413169 0
This outcome will use data from the baseline, check-in calls and 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.
Secondary outcome [12] 413170 0
Proportion of self-reported Serious Adverse Events (SAEs) and Adverse Events (AEs) (such as cough, throat/mouth irritation or nausea) at 19-month follow-up. The 19-month follow-up is a structured telephone interview conducted by a member of the research team.
Timepoint [12] 413170 0
The follow-up interview will occur 19-months after the participant's baseline interview completion date for ACTRN12621000076875.
Secondary outcome [13] 413171 0
Change in frequency of vaporised nicotine product use. All interviews are structured telephone interviews conducted by a trained interviewer and involves study-specific questions.
Timepoint [13] 413171 0
This outcome will use data from the check-in calls and 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.
Secondary outcome [14] 413172 0
Change in nicotine strength used in vaporised nicotine products. All interviews are structured telephone interviews conducted by a trained interviewer and involves study-specific questions.
Timepoint [14] 413172 0
This outcome will use data from the 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.
Secondary outcome [15] 413173 0
Change in flavours utilised in vaporised nicotine products. All interviews are structured telephone interviews conducted by a trained interviewer and involves study-specific questions.
Timepoint [15] 413173 0
This outcome will use data from the check-in calls and 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.
Secondary outcome [16] 413174 0
Method of obtaining vaporised nicotine products. All interviews are structured telephone interviews conducted by a trained interviewer and involves study-specific questions.
Timepoint [16] 413174 0
This outcome will use data from the 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.
Secondary outcome [17] 413175 0
Preferences for type of vaporiser device. All interviews are structured telephone interviews conducted by a trained interviewer and involves study-specific questions.
Timepoint [17] 413175 0
This outcome will use data from the check-in calls and 7-month follow-up interview from the main trial (ACTRN12621000076875) and the 19-month follow-up interview.

Eligibility
Key inclusion criteria
Participants can be included if they meet the primary outcome of six-month continuous abstinence in ACTRN12621000076875 (defined as self-report of having smoked less than or equal to 5 cigarettes in that time and carbon monoxide level of less than or equal to 5ppm using biochemical breath test verification) and provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be summarised using frequencies and percentages or means and standard deviations as appropriate. Prevalence of maintained smoking abstinence and maintained nicotine replacement product use will be estimated and the associated 95% confidence interval will be calculated using the Clopper-Pearson exact method.

Primary analysis will be conducted considering individuals with missing smoking status at follow-up as treatment failures. Sensitivity analyses will involve: (1) using multiple imputation to account for missing data; and (2) excluding participants with missing data.

Further details of all statistical analyses will be included in the statistical analysis plan (SAP).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2022
Actual
2/11/2022
Date of last participant enrolment
Anticipated
26/10/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
160
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311950 0
Charities/Societies/Foundations
Name [1] 311950 0
National Heart Foundation of Australia
Country [1] 311950 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 313436 0
None
Name [1] 313436 0
N/A
Address [1] 313436 0
N/A
Country [1] 313436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311380 0
UNSW HREC
Ethics committee address [1] 311380 0
Ethics committee country [1] 311380 0
Australia
Date submitted for ethics approval [1] 311380 0
07/12/2021
Approval date [1] 311380 0
09/12/2021
Ethics approval number [1] 311380 0
HC191025

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120898 0
Dr Ryan Courtney
Address 120898 0
National Drug and Alcohol Research Centre The University of New South Wales Sydney NSW 2052 Australia
Country 120898 0
Australia
Phone 120898 0
+61 2 9065 7655
Fax 120898 0
Email 120898 0
[email protected]
Contact person for public queries
Name 120899 0
Ryan Courtney
Address 120899 0
National Drug and Alcohol Research Centre The University of New South Wales Sydney NSW 2052 Australia
Country 120899 0
Australia
Phone 120899 0
+61 2 9065 7655
Fax 120899 0
Email 120899 0
[email protected]
Contact person for scientific queries
Name 120900 0
Ryan Courtney
Address 120900 0
National Drug and Alcohol Research Centre The University of New South Wales Sydney NSW 2052 Australia
Country 120900 0
Australia
Phone 120900 0
+61 2 9065 7655
Fax 120900 0
Email 120900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We plan to share fully anonymised individual participant data (IPD). All de-identified data of primary and secondary outcomes will be shared, excluding identifiable personal information (i.e., address details, contact information/details).
When will data be available (start and end dates)?
Following publication (data available for 15 years after study completion)
Available to whom?
Only bona fide research groups will be eligible to access data. Data access requests will be made via an application form detailing the specific requirements and the proposed research and publication plan. Data access requests will be reviewed against specific eligibility criteria by data custodians.
Available for what types of analyses?
Each application will be reviewed based on scientific quality and robustness of the proposed statistical analysis plan. Data request will be appraised by the Principal Investigator on a case-by-case basis.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]) and following approval will be sent via secure file transfer.


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
No additional documents have been identified.