Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000759695
Ethics application status
Approved
Date submitted
8/07/2014
Date registered
17/07/2014
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and efficacy of tobacco treatment interventions for smokers with a history of homelessness.
Scientific title
In smokers with a history of homelessness, does the provision of tobacco treatment interventions enhance access, treatment retention and cessation, if delivered within a residential community setting compared to an outpatient hospital setting.
Secondary ID [1] 284938 0
"Nil"
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation 292419 0
Condition category
Condition code
Mental Health 292734 292734 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once informed consent is obtained and smoking status is confirmed by CO measurement using a PICO+ Bedfont Smokerlyzer (CO <5ppm indicates a non-smoker), participants will be enrolled on the 12 week treatment trial (with nicotine replacement therapy administration) with 3 monthly follow-up for 9 months. The trial stages are as follows:

1. Participants will attend an initial tobacco assessment at Common Ground with a tobacco treatment counsellor who will administer a number of research questionnaires.

2. Participants will return the following week for the first of 12 x ½ hour, weekly, counselling sessions at Common Ground, with the study counsellor, at which time nicotine replacement therapy (NRT) will be dispensed and motivational intervewing commenced. Participants will commence on 21mg x 24 hour transdermal nicotine patch and/or one of the oral forms of NRT of the participant’s choice. The starting dose and type of NRT will be determined by an assessment of the patient's nicotine dependency and CO level. The dose of NRT will be titrated up to a maximum of 42mg transdermal nicotine patch in response to symptoms of withdrawal and relapse. Flexible NRT dosing will be provided according to the patient profile and clinician advice, based on the participant’s severity of dependence and previous experiences in using NRT.

3. At each weekly treatment session participants’ self-reported smoking level will be assessed and verified by CO measurement, as will NRT use, nicotine withdrawal symptoms and mental health issues. NRT will be dispensed at each weekly treatment session for 12 weeks. Motivational counselling interventions will be used throughout the treatment protocol to enhance motivation and readiness to quit smoking.

4.After 12 weeks of treatment, the provision of free NRT will cease but participants will have the option of obtaining a script for nicotine patches for a further 12 weeks if needed. The script will be provided by their medical practitioner.

5. Face-to-face follow-up interviews will be conducted at 3 monthly intervals for a period of 9 months following termination or treatment completion. Follow-up will include biochemical verification of self-reported smoking status in expired CO measurement, administration of the research questionnaires and a review of participants' medical records. Written consent will be obtained for access to participants’ medical records.
Intervention code [1] 289768 0
Treatment: Drugs
Intervention code [2] 289769 0
Behaviour
Comparator / control treatment
Once informed consent is obtained and smoking status is confirmed by CO measurement, participants will be enrolled on the 12 week treatment trial, using motivational interviewing counselling interventions only, with 3 monthly follow-up for 9 months. The trial stages are as follows:

1. Participants will attend an initial tobacco assessment with a tobacco treatment specialist who will administer a number of research questionnaires.
2. Participants will return the following week and attend further 12 x 1/2 hour weekly motivational interviewing counselling sessions.
3. At each treatment session, participants' self-reported smoking level will be assessed and verified by CO measurement, as will nicotine withdrawal symptoms, tobacco cravings and mental health.
4. After 12 weeks, participants will cease treatment and follow-up will commence. Face-to-face follow-up interviews will be conducted at 3 monthly intervals for a period of 9 months following termination or treatment completion. Follow-up will include biochemical verification of self-reported smoking status in expired CO measurement, administration of the research questionnaires and a review of participants' medical records. Written consent will be obtained for access to participants’ medical records.
Control group
Active

Outcomes
Primary outcome [1] 292585 0
Self-reported smoking cessation, verified by carbon monoxide (CO) measurement. A score CO<5ppm indicates a non-smoker
Timepoint [1] 292585 0
Timepoint: 3, 6 & 9 months after treatment commencement
Primary outcome [2] 292586 0
Attendance as measured by clinic records
Timepoint [2] 292586 0
13 weeks after commencement
Secondary outcome [1] 309266 0
Time to relapse as measure by self-report
Timepoint [1] 309266 0
3, 6 and 9 months after treatment commencement
Secondary outcome [2] 309267 0
Mental and physical health as measured by self-report and medical records
Timepoint [2] 309267 0
3, 6 & 9 months after treatment commencement

Eligibility
Key inclusion criteria
Intervention group:
* Currently smoke cigarettes (verified by CO measurement: CO >5ppm indicates a smoker)
* Assessed as nicotine dependent based on the Fagerstrom Test for Nicotine Dependence
*Interested in quitting smoking
* Current resident of Common Ground residential facility for homeless individuals
* Willing to use nicotine replacement therapy
Control group:

* Currently smoke cigarettes (verified by CO measurement: CO >5ppm indicates a smoker)
* Assessed as nicotine dependent based on the Fagerstrom Test for Nicotine Dependence
* Interested in quitting smoking
*Current patient of Royal Prince Alfred Hospital's outpatient Opioid Treatment Program
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant
* Young people under the age of 18 years
* People with cognitive impairment or an intellectual disability who are unable to give informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a small scale community-based pilot study, 30 participants will be recruited at each site

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/08/2014
Actual
16/06/2015
Date of last participant enrolment
Anticipated
Actual
5/04/2016
Date of last data collection
Anticipated
Actual
18/04/2017
Sample size
Target
60
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2712 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 8421 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 289566 0
Government body
Name [1] 289566 0
Sydney Local Health District
Country [1] 289566 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Drug Health Services
Level 6, King George V Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 288248 0
Charities/Societies/Foundations
Name [1] 288248 0
Common Ground
Mission Australia
Address [1] 288248 0
31 Pyrmont Bridge Road
Camperdown NSW 2050
Country [1] 288248 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291304 0
SLHD Ethics Review Committee (RPAH Zone) (EC00113)
Ethics committee address [1] 291304 0
Research Development Office
Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 291304 0
Australia
Date submitted for ethics approval [1] 291304 0
19/02/2014
Approval date [1] 291304 0
27/01/2015
Ethics approval number [1] 291304 0
SSA/14/RPAH/79

Summary
Brief summary
This project will explore the feasibility and treatment effectiveness of nicotine replacement therapy and motivational interventions for smokers who have a history of homelessness. It will evaluate the impact of treatment location on participation, retention and smoking cessation rates.
The trial design involves a treatment period of 12 weeks, with a further 9 months follow-up. Trial patient will be broken into two groups: (1) Thirty (30) trial participants who smoke and live in a housing facility for homeless people will receive motivationally-based counselling interventions and will commence on 21mg x 24 hour transdermal nicotine patch plus one of the forms of oral nicotine replacement therapy of the participant's choice. The dose of nicotine patch will be titrated up to a maximum of 42mg in response to withdrawal and relapse. Treatment will be delivered within the residential facility. (2) Thirty (30) trial participants attending a hospital-based opioid treatment program at Royal Prince Alfred Hospital, who smoke and have a history of homelessness, will receive motivational counselling interventions to help them to stop smoking. Treatment will be delivered within this outpatient facility.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47658 0
Prof Paul Haber
Address 47658 0
Medical Director
Drug Health Services
King George V Building
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 47658 0
Australia
Phone 47658 0
612 95155779
Fax 47658 0
Email 47658 0
[email protected]
Contact person for public queries
Name 47659 0
Ms Louise Ross
Address 47659 0
Tobacco Treatment Unit
Drug Health Services
Croydon Community Health Centre
24 Liverpool Road
Croydon NSW 2132
Country 47659 0
Australia
Phone 47659 0
612 9378 1306
Fax 47659 0
Email 47659 0
[email protected]
Contact person for scientific queries
Name 47660 0
Prof Paul Haber
Address 47660 0
Medical Director
Drug Health Services
King George V Building
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 47660 0
Australia
Phone 47660 0
612 95155779
Fax 47660 0
Email 47660 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

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