Cytisine for Smoking Cessation
Tobacco Use Disorder, Alcohol Use Disorder, Smoking Cessation
About this trial
This is an interventional treatment trial for Tobacco Use Disorder
Eligibility Criteria
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)
Sites / Locations
- Center for Addiction and Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Cytisine
Placebo
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)
Placebo will be given following the same schedule as the Cytisine Arm.