CompletedPhase 4

Cytisine for Smoking Cessation

Canada20 participantsStarted 2023-02-08

Plain-language summary

The goal of this clinical trial is to evaluate the safety and effectiveness of cytisine as a smoking cessation treatment in individuals with concurrent alcohol use disorder.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18-65 years; * Have TUD assessed by structured clinical interview for DSM-5; * Have past year AUD (active) assessed by structured clinical interview for DSM-5; * Report daily cigarette consumption in past month and expired carbon monoxide (CO) measurement ≥10ppm at screening; * Have Fagerstrom Test of Nicotine Dependence (FTND55) score ≥4; * Have motivation to quit within 30 days i.e. Contemplation Ladder56 score ≥7; * Be willing and able to comply with all study procedural and assessment demands; * Be able to provide voluntary written informed consent. Exclusion Criteria: * Report prolonged smoking abstinence in the past month preceding screening; * Be using other smoking cessation aids * Enrolled in another smoking cessation program * Be pregnant, breastfeeding, or intending to become pregnant or breastfeed; * Exhibit suicidal thoughts or behavior in the past month; * Enrolled in another study which would interfere with study procedures or represent a potential risk to the participant * Have a serious unstable psychiatric or medical condition preventing participation in the trial. This includes some forms of schizophrenia, ischemic heart disease, heart failure, arterial hypertension (systolic BP above 150; diastolic BP above 100), cerebrovascular diseases, occlusion of blood vessels, kidney and/or liver disease, hyperthyroidism, ulcer, diabetes, Chromaffin tumours of the adrenal medulla, and gastroesophageal reflux disease (GERD)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency and type of adverse events

Timeframe: Total duration of trial (24 weeks)

Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw

Timeframe: Total duration of trial (24 weeks)

Trial details

NCT IDNCT05729243

SponsorCentre for Addiction and Mental Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-12

View on ClinicalTrials.gov More Tobacco Use Disorder trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.