Overview
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.
Eligibility
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)