Cytisine for Smoking Cessation
- Conditions
- Alcohol Use DisorderTobacco Use DisorderSmoking Cessation
- Interventions
- Other: Placebo
- Registration Number
- NCT05729243
- Lead Sponsor
- Centre for Addiction and Mental Health
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be given following the same schedule as the Cytisine Arm. Cytisine Cytisine Cytisine will be given as 1.5 mg tablet formulations for 25 days. The following treatment schedule will be followed: * Days 1 to 3: 1.5 mg taken every 2 hours (6 pills (9 mg)/day) * Days 4 to 12: 1.5 mg taken every 2.5 hours (5 pills (7.5 mg)/day) * Days 13 to 16: 1.5 mg taken every 3 hours (4 pills (6 mg)/day) * Days 17 to 20: Taper down to 1 tablet every 5 hours (3 pills (4.5 mg)/day) * Days 21 to 25: Taper down to 1-2 tablets daily (1.5-3 mg/day)
- Primary Outcome Measures
Name Time Method Frequency and type of adverse events Total duration of trial (24 weeks) To assess the tolerability of cytisine
Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw Total duration of trial (24 weeks) To assess the tolerability of cytisine
- Secondary Outcome Measures
Name Time Method Nicotine Craving in Participants Throughout study duration (24 weeks) Tiffany Questionnaire of Smoking Urges (QSU) will be used to assess nicotine craving.
Repeated point-prevalence abstinence Throughout study completion, up to 24 weeks. Point-prevalence abstinence at each consecutive assessment point.
Point-prevalence abstinence Week 2 and week 4 Complete abstinence ("not even a puff") during a designated time period (7 days) prior to assessment. This will be measured at each assessment point (e.g., 2 and 4wk).
Prolonged abstinence This period will end at the end of treatment (day 25) or at final follow-up. Complete abstinence ("not even a puff") after an initial grace period; also known as sustained abstinence.
Prolonged abstinence with lapses This period will end at the end of treatment (day 25) or at final follow-up. Prolonged abstinence after a grace period, but some smoking is allowed (e.g., no more than 5 cigarettes; fewer than seven consecutive days of smoking).
Continuous Abstinence Throughout study completion, up to 24 weeks. Complete abstinence ("not even a puff") beginning on the TQD (i.e., with no grace period) and lasting until the assessment from target quit date (week 2) to end of treatment (day 25) and at final follow up.
Physical dependence to Nicotine in Participants Throughout study duration (24 weeks) The Fagerstrom Test for Nicotine Dependence (FTND) will be used to assess physical dependence in participants.
Nicotine Withdrawal Symptoms in Participants Throughout study duration (24 weeks) The Minnesota Nicotine Withdrawal Scale (MNWS) will be used to assess nicotine withdrawal symptoms.
Trial Locations
- Locations (1)
Center for Addiction and Mental Health
🇨🇦Toronto, Ontario, Canada