E-cigarettes vs usual care for smoking cessation when offered at homeless centres

Not Applicable

• Conditions: Smoking cessation for tobacco dependence; Mental and Behavioural Disorders

• Registration Number: ISRCTN18566874
• Lead Sponsor: ondon South Bank University

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35194862/ (added 19/01/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Last Update Posted: 2 September 2024
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 477

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 27/07/2022:<br>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).<br><br>_____<br><br>Previous primary outcome measure:<br>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)