Clinical trial NCT05729243: Cytisine for Smoking Cessation
Official title: Cytisine: Testing Its Potential as a Therapeutic Strategy for Smoking Cessation Among People With Concurrent Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tobacco Use Disorder
Alcohol Use Disorder
Smoking Cessation
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: Frequency and type of adverse events
timeFrame: Total duration of trial (24 weeks)
measure: Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw
timeFrame: Total duration of trial (24 weeks)
Secondary outcomes:
measure: Point-prevalence abstinence
timeFrame: Week 2 and week 4
measure: Repeated point-prevalence abstinence
timeFrame: Throughout study completion, up to 24 weeks.
measure: Prolonged abstinence
timeFrame: This period will end at the end of treatment (day 25) or at final follow-up.
measure: Prolonged abstinence with lapses
timeFrame: This period will end at the end of treatment (day 25) or at final follow-up.
measure: Continuous Abstinence
timeFrame: Throughout study completion, up to 24 weeks.
measure: Physical dependence to Nicotine in Participants
timeFrame: Throughout study duration (24 weeks)
measure: Nicotine Withdrawal Symptoms in Participants
timeFrame: Throughout study duration (24 weeks)
measure: Nicotine Craving in Participants
timeFrame: Throughout study duration (24 weeks)
Other outcomes:
measure: Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on anxiety.
timeFrame: Throughout study duration (24 weeks)
measure: Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on mood.
timeFrame: Throughout study duration (24 weeks)
measure: Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on Quality of Life.
timeFrame: Throughout study duration (24 weeks)
measure: Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by collecting the number of drinking days in participants.
timeFrame: Throughout study duration (24 weeks)
measure: Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by measuring the proportion of heavy drinking days in participants.
timeFrame: Throughout study duration (24 weeks)
measure: Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by measuring the proportion of participants without heavy drinking days.
timeFrame: Throughout study duration (24 weeks)
Locations:
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: The Centre for Addiction and Mental Health
name: Bernard Le Foll
role: PRINCIPAL_INVESTIGATOR
References: