Smoking cessation Mental and Behavioural Disorders
Conditions
Interventions
This will be a three-arm individually randomised controlled effectiveness trial.
Those who are eligible and consent to participate in the trial will be randomised after completing the baseline quest
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years old (as cytisine is available for prescription in UK to adults 18-65 years old) 2. Able to consent 3. Residing in the UK 4. English speaking 5. Current cigarette smoker 6. Willing to be followed up by email and complete online questionnaires after two and seven months 7. Interested in making a quit attempt within the next month 8. Have downloaded and signed up to the Smoke Free app within the past week during the recruitment period, and have set a quit date no more than 30 days in the future
Exclusion criteria
Exclusion criteria: 1. Current enrolment in another smoking cessation programme/study 2. Current use of smoking cessation medication 3. Varenicline and/or cytisine use in the previous 12 months 4. Pregnant/breastfeeding/planning to get pregnant 5. Self-reported moderate/severe renal impairment 6. Treatment for active/latent tuberculosis 7. Experience of a heart attack, stroke or severe angina within the previous two weeks 8. Uncontrolled high blood pressure (> 150 mmHg systolic, > 100 mmHg diastolic) 9. History of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The percentage of participants reporting medication use (varenicline or cytisine use) measured using an online questionnaire at the 2-month follow-up 2. The percentage of participants reporting varenicline or cytisine use among those recommended one of them measured using an online questionnaire at the 2-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 06/02/2026: The following secondary outcome measures assess the percentage of participants reporting: 1. Attempts to obtain stop-smoking medication in the past two months, assessed using an online questionnaire at the 2-month follow-up 2. Continuous abstinence for one month measured using an online questionnaire at 2-month follow-up 3. Biochemically-verified continuous smoking abstinence for 6 months measured using data from a CO monitor at the 7-month follow-up by a) group allocation and b) by use of recommended medication Previous secondary outcomes: The following secondary outcome measures assess the percentage of participants reporting: 1. Continuous abstinence for one month measured using an online questionnaire at 2-month follow-up. 2. Biochemically-verified continuous smoking abstinence for six months measured using data from a CO monitor at the 7-month follow-up by a) group allocation and b) by use of recommended medication | — |
Countries
United Kingdom
Contacts
Public ContactDimitra Kale
Outcome results
None listed