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Feasibility and efficacy of tobacco treatment interventions for smokers with a history of homelessness.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000759695
Enrollment
30
Registered
2014-07-17
Start date
2015-06-16
Completion date
2016-04-05
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 questionna

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.

Sponsors

Royal Prince Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026