Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001564145
Ethics application status
Approved
Date submitted
25/09/2019
Date registered
13/11/2019
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing Smoking in Sheltered homeless with Intensive Smoking Treatment
Scientific title
A feasibility study examining the safety of varenicline, combination nicotine replacement therapy and counselling in male adult tobacco smokers at risk or experiencing homelessness.
Secondary ID [1] 299414 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ASSIST (Addressing Smoking in Sheltered homeless with Intensive Smoking Treatment)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nicotine Dependence 314585 0
Condition category
Condition code
Public Health 312926 312926 0 0
Health service research
Mental Health 312927 312927 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All study participants will receive the study intervention. Participants will be provided behavioural and pharmacological strategies to treat their nicotine dependence for 12 weeks. Behavioural supports will include counselling for nicotine dependence, specifically motivational interviewing. Pharmacological support include a prescription of varenicline and provision of combination nicotine replacement therapy (quick mist, inhalator, patch, gum, lozenge). The research assistant will provide training to the participant on the proper use, benefits, and side effects associated with the study allocated products (Varenicline and NRT). Varenicline will be prescribed by a physician employed by the study site.

Counselling
Participants will receive a weekly individual counselling session (approximate duration of 5 to 10 minutes) with the study research assistants. These sessions will be face to face however there will be the option of over the phone consultations. Counselling will draw upon motivational interviewing techniques.

Nicotine Replacement Therapy
Provision of 12 weeks of combination nicotine replacement therapy (patches, quick mist, inhalator, gum, and lozenge) will be provided. Participants will be provided NRT in 4-week supplies. For weeks 1-4 participants will be provided patches (21mg) plus inhalator (15mg) and quick mist (1mg/spray). Weeks 5-8 participants will be provided with patches (21mg) plus inhalator (15mg), lozenges (4mg), and gum (4mg). For week 9-12 participants will be provided with patches (21mg), lozenges (4mg), and gum (4mg).

Recommended frequency of each form of NRT as provided to participants:
Patch (21mg): Put on a new patch every morning.
Gum: Use 6-10 pieces of gum per day, with a maximum of 10 per day.
Inahlator: use a single nicotine inhalator cartridge over 20-30 minutes (no more than one hour). No more than 6 cartridges over a 24 hour period.
Lozenge: Do not exceed 15 lozenges per day.
Quickmist: Use of maximum of 2 sprays at a time and not more than 4 in one hour.

Check-in safety and product re-fills calls will be conducted during the study period. This will document whether the participant would like their product re-fills (for Weeks 5-8 and 9-12) and amount of products remaining.

Varenicline
Varenicline will be provided as oral tablets. In line with the product disclosure statement and previous safety trials we will provide dosing as follows:
Days 1-3: one 0.5mg tablet once daily
Days 4-7: one 0.5mg tablet twice daily
Day 8- 84: one 1mg tablet twice daily
Intervention code [1] 315661 0
Treatment: Drugs
Intervention code [2] 315662 0
Behaviour
Comparator / control treatment
This is a single arm feasibility study. It is an uncontrolled pre and post test study design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321526 0
Safety will be measured by examining the number of adverse events/ SAE’s (related and unrelated to study intervention).

Below is a list of examples of known/possible adverse events.

Bronchitis (coughing up thickened mucus and shortening of breath); Gastroenteritis (diarrhoea, cramps, nausea, vomiting and fever); Increased weight; Increased appetite; Anxiety; Depressed mood; Insomnia; Cough; Abdominal pain or discomfort; Reflux; Body pain, including joints and muscles; Fatigue or lack of energy; Mouth ulcer; Irregular heartbeat.
Timepoint [1] 321526 0
Participants will be encouraged to report adverse events experienced throughout the duration of the study however, they will be asked to report adverse events directly at the safety and product re-fills check-in scheduled from one week post intervention commencement and fortnightly check-ins until week 11.
Secondary outcome [1] 375241 0
Feasibility of a smoking cessation intervention at a primary health clinic at a hostel. Composite secondary outcome will be assessed by examining recruitment rate and retention rate (at 12 weeks post baseline/ intervention allocation); reason for study exclusion, non-consent (if provided) or withdrawal from the study.
Timepoint [1] 375241 0
Assessed at 12 weeks from baseline survey completion and study intervention commencement.
Secondary outcome [2] 375242 0
Potential effectiveness on smoking cessation.
Composite secondary outcome, with specific outcomes defined below. Assessment tools used to measure the outcome are defined in brackets after the outcome:
• Number of individuals that quit on tobacco quit date, measured at Week 3 (Did you quit on your target quit date?)
• Number of individuals reporting continuous abstinence from tobacco quit date, measured at Week 12 (Have you smoked at all since the target quit date (one week post commencement of study allocated products ): a. No, not a puff, b. 1-5 cigarettes, c. more than 5 cigarettes.)
• Number of individuals reporting smoking cessation for the past 30 days, measured at Week 12 (Have you smoked a cigarette in the past 30 days? a. no, not a puff, b. 1-5 cigarettes, c. more than 5 cigarettes).
• Number of individuals reporting smoking cessation in the past 7 day point prevalence abstinence, measured at Week 12 (Have you smoked a cigarette, even a puff in the past 7 days? AND as measured biochemically via the Smokelyzer with a threshold of 10ppm or higher to indicate having smoked a cigarette)

Assessment outcomes taken from previous research examining quit attempts and success, with Piper et al. (2019) as a guide.
Piper, M. E., Bullen, C., Krishnan-Sarin, S., Rigotti, N. A., Steinberg, M. L., Streck, J. M., & Joseph, A. M. (2019). Defining and measuring abstinence in clinical trials of smoking cessation interventions: An updated review. Nicotine & Tobacco Research.
Timepoint [2] 375242 0
Assessed at 12 weeks from baseline survey completion and study intervention commencement.
Secondary outcome [3] 375243 0
Adherence to varenicline, NRT, counselling composite secondary outcome, with specific outcomes defined below. Assessment tools used to measure the outcome are defined in brackets after the outcome:
•Adherence to prescribed Varenicline, receipt of prescriptions, reasons for non-compliance. How much they use (Have you used the Varenicline provided as part of the study in the last two weeks? Please specify what has stopped you from using Varenicline? On how many days have you used the Varenicline in the past 2 weeks?)
•Adherence to NRT (receipt of packs), reasons for non-compliance/ use, daily or non-daily use (Have you used the NRT provided as part of the study in the last two weeks?; Please specify what has stopped you from using NRT?; On how many days have you used the NRT in the past 2 weeks?)
•mean number of counselling sessions attended, average length of counselling session, topics discussed in counselling (Did you attend counselling in the last two weeks?; Please specify what has stopped you from attending counselling?; How long was the first session?; How long was the second session?; What topics did you discuss?)
Timepoint [3] 375243 0
Assessed at baseline and 12 weeks survey as well as safety and product-refill calls/ check-ins. Safety calls/check ins occur at Week 1, 3, 5, 7, 9, 11, and 12. Product refill calls/check ins occur at Week 3 and 7.
Secondary outcome [4] 375244 0
Psychological Distress
Assessment of psychological distress compared to baseline using Kessler 10
Timepoint [4] 375244 0
Assessed at 12 weeks from baseline survey completion and study intervention commencement.
Secondary outcome [5] 375245 0
Nicotine Dependence
Level of nicotine dependence will be measured by the two item heaviness of smoking index at baseline and then 12 weeks.
Timepoint [5] 375245 0
Assessed at baseline and 12 weeks from baseline survey completion/study intervention commencement.
Secondary outcome [6] 375246 0
Quit attempts
Number and length of quit attempts in the last 12 weeks (In the last 12 weeks, have you tried to make a quit attempt, where you did not smoke a cigarette for at least one day?; In the last 12 weeks how many times have you made a quit attempt where you did not smoke for at least 24 hours? In the last 12 weeks, have you tried to reduce the number of cigarettes you smoke in order to quit?)

Items developed from previous research that we have conducted examining smoking quit attempts (ACTRN12617000905369).
Timepoint [6] 375246 0
Assessed at baseline and 12 weeks from baseline survey completion/study intervention commencement.
Secondary outcome [7] 375247 0
Motivation to quit
A single motivation item to assess motivation to quit (On a scale of one to ten rate your current motivation to give up smoking (where 1 = very low motivation to 10=very high motivation)).

Assessed at baseline and only assessed with participants who do not report cessation at the 12 week survey. Assessment items were developed based on previous research conducted by the research team.
Timepoint [7] 375247 0
Assessed at baseline and 12 weeks from baseline survey completion/study intervention commencement.
Secondary outcome [8] 375248 0
Relapse
Relapse is defined as a period of seven consecutive days of tobacco smoking after a period of abstinence (Have you returned to tobacco smoking for a period of 7 or more consecutive days?). This item was created by the research team based on prior research examining smoking relapse definitions. Number of relapses to smoking will be reported at the 12 week follow-up survey.
Timepoint [8] 375248 0
Assessed at 12 weeks from baseline survey completion/study intervention commencement.
Secondary outcome [9] 375249 0
Nicotine Withdrawal
Symptoms associated with nicotine withdrawal will be measured by the Minnesota Nicotine Withdrawal Scale at baseline and 12 weeks after intervention commencement.
Timepoint [9] 375249 0
Assessed at baseline and 12 weeks from baseline survey completion/study intervention commencement.
Secondary outcome [10] 375250 0
Cravings- composite secondary outcome consisting of assessing both frequency and strength of urge to smoke:
• Frequency of urges to smoke, measured at Baseline and Week 12 (How much of the time have you felt the urge to smoke in the past 24 hours?)
• Strength of urges to smoke, measured at Baseline and Week 12 (How strong have the urges to smoke been in the past 24 hours?)

These measures are commonly used in smoking cessation research. As exemplified in the following article: Taggar, J. S., Lewis, S., Docherty, G., Bauld, L., McEwen, A., & Coleman, T. (2015). Do cravings predict smoking cessation in smokers calling a national quit line: secondary analyses from a randomised trial for the utility of ‘urges to smoke’measures. Substance abuse treatment, prevention, and policy, 10(1), 15.
Timepoint [10] 375250 0
Assessed at baseline and 12 weeks from baseline survey completion/study intervention commencement.
Secondary outcome [11] 376763 0
Self-efficacy to quit.

A single item will assess self-efficacy to quit (If you decided to quit smoking completely, how sure are you that you would succeed?)
Timepoint [11] 376763 0
Assessed at baseline and 12 weeks from baseline survey/ study intervention commencement.
Secondary outcome [12] 376770 0
Acceptability of varenicline
Composite measure. Asking participants to rate on a scale from strongly disagree to strongly agree seven statements that measure affective attitude, burden, perceived effectiveness, ethically, intervention coherence, opportunity costs, and self-efficacy of the varenicline.

Assessed using composite measures: number of counselling sessions attended, average length of counselling sessions and topics discussed; number of participants utilising allocated study products; number of participants accepting the re-fill study intervention packs; attitudes regarding the different components of the intervention will be measured by asking participants to indicate how strongly they agree or disagree with a number of statements that will be assessed on a five point likert scale from strongly disagree to strongly agree.
Timepoint [12] 376770 0
Assessed at 12 weeks from baseline survey completion and study intervention commencement.
Secondary outcome [13] 376771 0
Acceptability of NRT
Composite measure. Asking participants to rate on a scale from strongly disagree to strongly agree seven statements that measure affective attitude, burden, perceived effectiveness, ethically, intervention coherence, opportunity costs, and self-efficacy of the NRT
Timepoint [13] 376771 0
Assessed at 12 weeks from baseline survey completion and study intervention commencement.
Secondary outcome [14] 376772 0
Acceptability of counselling.
Composite measure. Asking participants to rate on a scale from strongly disagree to strongly agree seven statements that measure affective attitude, burden, perceived effectiveness, ethically, intervention coherence, opportunity costs, and self-efficacy of the counselling.
Timepoint [14] 376772 0
Assessed at 12 weeks from baseline survey completion and study intervention commencement.

Eligibility
Key inclusion criteria
(i) Aged at least 18 years
(ii) Is of male sex
(iii) Smoking greater than or equal to 10 cigarettes per day
(iv) Wanting to quit smoking in the next 30 days
(v) Currently accessing the primary health clinic at the St Vincent de Paul’s Matthew Talbot Hostel in Woolloomooloo, Sydney.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
(i) currently engaged in telephone smoking cessation counselling
(e.g. quit line) or formal smoking cessation counselling
service/program (e.g. smoking cessation clinic)
(ii) inability to complete informed consent and/or the screening
survey (e.g. do not have capacity to consent, insufficient English
language comprehension)
(iii) currently prescribed varenicline or bupropion, or nicotine
replacement therapy
(iv) currently enrolled in another study
(v) Weight <45 kgs.
(vi) Have contraindications for NRT or Varenicline
a. had recent (within 2 weeks) either a heart attack or severe
arrhythmia
b. have unstable angina

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size
Given this study is a pilot feasibility study and our primary outcome is to determine the safety of the study intervention as such we will recruit 20 participants. This sample size is large enough to examine the feasibility and acceptability without placing undue burden on a larger number of participants. Similar sample sizes have been recruited in our previous pilot study research, as well as in other studies of similar designs.

Statistical Analysis
Independent statisticians from the CReDITSS Unit at the University of Newcastle will review the statistical analysis plan and provide suggestions. CReDITSS will also conduct analyses of the primary and secondary outcomes for the study. Briefly, descriptive analyses including summaries (percentages or means and 95% Cis) for participant demographics and baseline characteristics and each outcome at baseline or follow-up will be provided.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/11/2019
Actual
Date of last participant enrolment
Anticipated
19/12/2019
Actual
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28135 0
2011 - Woolloomooloo

Funding & Sponsors
Funding source category [1] 303921 0
Other Collaborative groups
Name [1] 303921 0
Stroud Rodeo Pilot Grant- Hunter Medical Research Institute
Country [1] 303921 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
1 University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 304072 0
None
Name [1] 304072 0
Address [1] 304072 0
Country [1] 304072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304422 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 304422 0
Ethics committee country [1] 304422 0
Australia
Date submitted for ethics approval [1] 304422 0
17/05/2019
Approval date [1] 304422 0
19/09/2019
Ethics approval number [1] 304422 0
H-2019-0216

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

Contacts
Principal investigator
Name 96902 0
Dr Eliza Skelton
Address 96902 0
Centre for Brain and Mental Health Research
Level 5 McAuley Building, Calvary Mater Hospital
Waratah, NSW, 2298
Country 96902 0
Australia
Phone 96902 0
+61240335040
Fax 96902 0
Email 96902 0
[email protected]
Contact person for public queries
Name 96903 0
Eliza Skelton
Address 96903 0
Centre for Brain and Mental Health Research
Level 5 McAuley Building, Calvary Mater Hospital
Waratah, NSW, 2298
Country 96903 0
Australia
Phone 96903 0
+61240335040
Fax 96903 0
Email 96903 0
[email protected]
Contact person for scientific queries
Name 96904 0
Eliza Skelton
Address 96904 0
Centre for Brain and Mental Health Research
Level 5 McAuley Building, Calvary Mater Hospital
Waratah, NSW, 2298
Country 96904 0
Australia
Phone 96904 0
+61240335040
Fax 96904 0
Email 96904 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for data sharing was not sought.


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.