Cytisine for Smoking Cessation

Centre for Addiction and Mental Health20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Tobacco Use Disorder Alcohol Use Disorder Smoking Cessation

Interventions

CytisineDRUG

Cytisine is a nicotinic acetylcholine receptor partial agonist and is a natural health product approved by Health Canada. Cytisine has been used for a long time in Europe for smoking cessation.

PlaceboOTHER

A placebo identical in appearance to cytisine will be used

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Center for Addiction and Mental Health

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Frequency and type of adverse events

To assess the tolerability of cytisine

Time frame: Total duration of trial (24 weeks)

Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw

To assess the tolerability of cytisine

Time frame: Total duration of trial (24 weeks)

Secondary Outcomes

Point-prevalence abstinence

Complete abstinence ("not even a puff") during a designated time period (7 days) prior to assessment. This will be measured at each assessment point (e.g., 2 and 4wk).

Time frame: Week 2 and week 4

Repeated point-prevalence abstinence

Point-prevalence abstinence at each consecutive assessment point.

Time frame: Throughout study completion, up to 24 weeks.

Prolonged abstinence

Complete abstinence ("not even a puff") after an initial grace period; also known as sustained abstinence.

Time frame: This period will end at the end of treatment (day 25) or at final follow-up.

Prolonged abstinence with lapses

Prolonged abstinence after a grace period, but some smoking is allowed (e.g., no more than 5 cigarettes; fewer than seven consecutive days of smoking).

Time frame: This period will end at the end of treatment (day 25) or at final follow-up.

Continuous Abstinence

Complete abstinence ("not even a puff") beginning on the TQD (i.e., with no grace period) and lasting until the assessment from target quit date (week 2) to end of treatment (day 25) and at final follow up.

Data from ClinicalTrials.gov

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