Smoking cessation for tobacco dependence Mental and Behavioural Disorders
Conditions
Interventions
Current intervention as of 27/07/2022:
Cluster rather than individual randomisation will be used. Hence the clusters/unit of randomisation in the study are the homeless centres. Centres will be alloca
Cox et al., 2021). Centre staff will provide EC arm participants with a tank-style refillable EC starter kit (e.g. the PockeX as used in our feasibility study or similar model determined via our PPI w
Sponsors
London South Bank University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/07/2023: 1. Persons aged 18 years or older 2. Self-reported daily smoking (confirmed by homeless centre staff and then biochemically verified by exhaled CO at recruitment) 3. Currently accessing homeless centre services and actively engaging with the service (determined by homeless centre staff) 4. Willing and able to provide written consent (a translator can be provided) Previous inclusion criteria: 1. Persons aged 18 years or older 2. Self-reported daily smoking (confirmed by homeless centre staff and then biochemically verified by exhaled CO at recruitment) 3. Currently accessing homeless centre services and actively engaging with the service (determined by homeless centre staff)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 27/07/2022: 1. Never or former smoker 2. Those currently using a smoking cessation aid 3. Unable to provide written consent at the present time (e.g. due to current intoxication or distress) 4. Not known to centre staff 5. Allergic to any of the e-liquid ingredients (EC arm only) _____ Previous exclusion criteria 1. Never and ex-smokers 2. Those currently using another smoking cessation aid 3. Pregnant (although this will be reviewed in light of ongoing evidence) 4. Unable to provide written consent at the present time (e.g. due to current intoxication or distress)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/07/2022: Sustained CO validated smoking cessation at 24 weeks using the Russell Standard for cessation trials and intention to treat analysis (i.e. no more than 5 cigarettes since 2 weeks from baseline, validated by expired CO <8ppm. Participants lost to follow-up are treated as non-abstainers). _____ Previous primary outcome measure: Sustained CO validated smoking cessation at 24 weeks using the Russell Standard for cessation trials and intention to treat analysis (i.e. no more than 5 cigarettes since 2 weeks post target quit date [TQD] validated by expired CO <8ppm. Participants lost to follow-up are treated as non-abstainers) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 27/07/2022: 1. Smoking reduction at 24 weeks measured by subtracting the number of cigarettes smoked per day at follow up from the number of cigarettes smoked per day at baseline 2. 7-day point prevalence quit rates at 4, 12 and 24 weeks measured using self reported cigarettes smoked in the last 7-days at follow-up and validated by expired CO <8ppm. 3. Changes in the frequency of risky smoking practices (e.g. sharing cigarettes, smoking discarded cigarettes) from baseline to 4, 12 and 24 weeks measured using self report engagement in these behaviours 4. Cost-effectiveness of the intervention measured using a service use questionnaire and the EQ-5D-5L (service use questionnaire includes NHS and PSS costs, patients' out of pocket expenditure on cessation aids, travel costs when accessing NHS/PSS health care and lost productivity from work for those working) at baseline and each follow up time point (4, 12, 24 weeks) 5. Fidelity of intervention implementation measured using ethnographic observations and a checklist confirming implementation at weeks 3-4 6. Mechanisms of change measured quantitatively via questions (e.g. attitudes and perceptions of e-cigs) inserted into follow-up assessments (via questionnaires) and qualitatively via semi-structure interviews with staff between weeks 4-8 and with participants between weeks 12-24 7. Contextual influences and sustainability measured using semi-structured telephone interviews with staff in the e-cigarette arm between weeks 4-8 _____ Previous secondary outcome measures: 1. Smoking reduction at 24 weeks measured by subtracting the number of cigarettes smoked per day at follow up from the number of cigarettes smoked per day at baseline 2. 7-day point prevalence quit rates at 4, 12 and 24 weeks measured using self reported cigarettes smoked in the last 7-days at follow-up 3. Changes in risky smoking practices (e.g. sharing cigarettes, smoking discarded cigarettes) from baseline to 4, | — |
Countries
United Kingdom
Contacts
Public ContactSharon;Kirstie Cox;Soar
;
Outcome results
None listed