Addressing Smoking in Sheltered homeless with Intensive Smoking Treatment
A feasibility study examining the safety of varenicline, combination nicotine replacement therapy and counselling in male adult tobacco smokers at risk or experiencing homelessness.
The University of Newcastle
20 participants
Nov 13, 2019
Interventional
Conditions
Summary
A single arm feasibility study of an 12-week smoking cessation intervention consisting of varenicline, combination nicotine replacement therapy, and counselling (motivational interviewing) among men at risk or experiencing homelessness and attending a healthcare clinic. The primary aims of the feasibility study is to assess the safety of the intervention (as recorded by number of adverse events, serious adverse events). If the intervention is found to be feasible and safety for this population this intervention could be implemented as part of standard practice and a model for other healthcare clinics treating this high priority population for tobacco smoking.
Eligibility
Inclusion Criteria5
- (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.
Exclusion Criteria14
- (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
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Interventions
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
Locations(1)
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ACTRN12619001564145