Cytisine for Smoking Cessation

Center for Addiction and Mental Health (CAMH)

Status and phase: Enrolling; Phase 4

Conditions: Tobacco Use Disorder; Smoking Cessation; Alcohol Use Disorder

Treatments: Drug: Cytisine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05729243

054-2022

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Cytisine

Experimental group

Description:

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)

Treatment:

Drug: Cytisine

Placebo

Placebo Comparator group

Description:

Placebo will be given following the same schedule as the Cytisine Arm.

Treatment:

Other: Placebo