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)