Do e-cigarettes help smokers quit when not accompanied by intensive behavioural support?

Do e-cigarettes help smokers quit when not accompanied by intensive behavioural support? A multi-center randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61193406

Enrollment

1170

Registered

2020-08-11

Start date

2021-09-01

Completion date

Unknown

Last updated

2025-03-10

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

Conditions

Smoking cessation Mental and Behavioural Disorders Mental and behavioural disorders due to use of tobacco

Interventions

Current interventions as of 16/03/2021: Participants will be randomised to one of three interventions (detailed below). Randomisation (1:1:1) in permuted blocks will be undertaken using a web-based

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Daily smoker 3. Motivated to stop smoking 4. Owns a mobile phone 5. Willing to try either an online and/or texting treatment package or EC with or without telephone support and to receive follow-up calls 6. Able to read/write/understand English 7. Has an email address (added 16/03/2021)

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Current (at least weekly) use of EC

Design outcomes

Primary

Measure	Time frame
Sustained smoking cessation at 6 months post-TQD. This is measured by asking participants if they have smoked since their TQD at the 6-month follow-up. To be counted as a 'quitter', participants must report smoking no more than five cigarettes since two-weeks post-TQD with no smoking in the previous week, validated by carbon monoxide (CO) reading of < 8ppm. Participants lost-to-follow-up will be counted as smokers.	—

Measure

Time frame

Sustained smoking cessation at 6 months post-TQD. This is measured by asking participants if they have smoked since their TQD at the 6-month follow-up. To be counted as a 'quitter', participants must report smoking no more than five cigarettes since two-weeks post-TQD with no smoking in the previous week, validated by carbon monoxide (CO) reading of < 8ppm. Participants lost-to-follow-up will be counted as smokers.

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Secondary

Measure	Time frame
1. Validated sustained abstinence rates measured by asking smoking status and taking a carbon-monoxide reading at 12 months post-TQD 2. Validated sustained abstinence rates between 6 and 12 months, measured by asking smoking status and taking a carbon-monoxide reading at 6 and 12 months 3. Self-reported 7-day point-prevalence abstinence, measured by asking smoking status in last 7 days at 4 weeks, 6 months and 12 months post-TQD 4. Cigarette consumption in non-abstainers by vaping status, measured by questionnaire at four weeks, 6 and 12 months 5. Frequency and severity of urges to smoke and withdrawal symptoms, measured by questionnaire at 4 weeks post-TQD. 6. Weight, measured by asking weight at 4 weeks, 6 months and 12 months post-TQD 7. Respiratory symptoms, measured by questionnaire, at 4 weeks, 6 months and 12 months post-TQD 8. Treatment adherence and ratings, measured by questionnaire at 4 weeks (and 6 and 12 months for EC arms) 9. Adverse reactions to EC, measured by questionnaire at 4 weeks, 6 and 12 months post-TQD 10. Cost-effectiveness of the interventions, measured by questionnaires at baseline, 6 and 12 months 11. Smokers' and health-care professionals views and opinions of the helpline, measured by one-off qualitative interviews separate to the main trial	—

Measure

Time frame

1. Validated sustained abstinence rates measured by asking smoking status and taking a carbon-monoxide reading at 12 months post-TQD 2. Validated sustained abstinence rates between 6 and 12 months, measured by asking smoking status and taking a carbon-monoxide reading at 6 and 12 months 3. Self-reported 7-day point-prevalence abstinence, measured by asking smoking status in last 7 days at 4 weeks, 6 months and 12 months post-TQD 4. Cigarette consumption in non-abstainers by vaping status, measured by questionnaire at four weeks, 6 and 12 months 5. Frequency and severity of urges to smoke and withdrawal symptoms, measured by questionnaire at 4 weeks post-TQD. 6. Weight, measured by asking weight at 4 weeks, 6 months and 12 months post-TQD 7. Respiratory symptoms, measured by questionnaire, at 4 weeks, 6 months and 12 months post-TQD 8. Treatment adherence and ratings, measured by questionnaire at 4 weeks (and 6 and 12 months for EC arms) 9. Adverse reactions to EC, measured by questionnaire at 4 weeks, 6 and 12 months post-TQD 10. Cost-effectiveness of the interventions, measured by questionnaires at baseline, 6 and 12 months 11. Smokers' and health-care professionals views and opinions of the helpline, measured by one-off qualitative interviews separate to the main trial

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Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026