← Back to all trials
Not Yet Recruiting
NCT05729243
Cytisine for Smoking Cessation
Conditions: Tobacco Use Disorder, Alcohol Use Disorder, Smoking Cessation
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE4
Enrollment: 48
Sponsor: Centre for Addiction and Mental Health
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.
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 aidsEnrolled in another smoking cessation programBe 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 participantHave 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)
Source: ClinicalTrials.gov (NCT05729243). StuddyBuddy aggregates publicly available trial information.