Back to resultsCytisine for Smoking Cessation
Primary Purpose
Tobacco Use Disorder, Alcohol Use Disorder, Smoking Cessation
Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Cytisine
Placebo
Sponsored by
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
Arm Type
Experimental
Placebo Comparator
Arm Label
Cytisine
Placebo
Arm 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)
Placebo will be given following the same schedule as the Cytisine Arm.
Outcomes
Primary Outcome Measures
Frequency and type of adverse events
To assess the tolerability of cytisine
Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw
To assess the tolerability of cytisine
Secondary Outcome Measures
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).
Repeated point-prevalence abstinence
Point-prevalence abstinence at each consecutive assessment point.
Prolonged abstinence
Complete abstinence ("not even a puff") after an initial grace period; also known as sustained abstinence.
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).
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.
Physical dependence to Nicotine in Participants
The Fagerstrom Test for Nicotine Dependence (FTND) will be used to assess physical dependence in participants.
Nicotine Withdrawal Symptoms in Participants
The Minnesota Nicotine Withdrawal Scale (MNWS) will be used to assess nicotine withdrawal symptoms.
Nicotine Craving in Participants
Tiffany Questionnaire of Smoking Urges (QSU) will be used to assess nicotine craving.
Full Information
NCT ID
NCT05729243
First Posted
January 24, 2023
Last Updated
April 4, 2023
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT05729243
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Alcohol Use Disorder, Smoking Cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cytisine
Arm Type
Experimental
Arm 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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be given following the same schedule as the Cytisine Arm.
Intervention Type
Drug
Intervention Name(s)
Cytisine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A placebo identical in appearance to cytisine will be used
Primary Outcome Measure Information:
Title
Frequency and type of adverse events
Description
To assess the tolerability of cytisine
Time Frame
Total duration of trial (24 weeks)
Title
Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw
Description
To assess the tolerability of cytisine
Time Frame
Total duration of trial (24 weeks)
Secondary Outcome Measure Information:
Title
Point-prevalence abstinence
Description
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
Title
Repeated point-prevalence abstinence
Description
Point-prevalence abstinence at each consecutive assessment point.
Time Frame
Throughout study completion, up to 24 weeks.
Title
Prolonged abstinence
Description
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.
Title
Prolonged abstinence with lapses
Description
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.
Title
Continuous Abstinence
Description
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.
Time Frame
Throughout study completion, up to 24 weeks.
Title
Physical dependence to Nicotine in Participants
Description
The Fagerstrom Test for Nicotine Dependence (FTND) will be used to assess physical dependence in participants.
Time Frame
Throughout study duration (24 weeks)
Title
Nicotine Withdrawal Symptoms in Participants
Description
The Minnesota Nicotine Withdrawal Scale (MNWS) will be used to assess nicotine withdrawal symptoms.
Time Frame
Throughout study duration (24 weeks)
Title
Nicotine Craving in Participants
Description
Tiffany Questionnaire of Smoking Urges (QSU) will be used to assess nicotine craving.
Time Frame
Throughout study duration (24 weeks)
Other Pre-specified Outcome Measures:
Title
Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on anxiety.
Description
Anxiety will be measured through the General Anxiety Disorder-7 (GAD-7) questionnaire.
Time Frame
Throughout study duration (24 weeks)
Title
Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on mood.
Description
Mood will be measured by the Patient Health Questionnaire-9 (PHQ-9).
Time Frame
Throughout study duration (24 weeks)
Title
Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on Quality of Life.
Description
Quality of Life will be measured through the WHO Disability Assessment Schedule (WHODAS).
Time Frame
Throughout study duration (24 weeks)
Title
Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by collecting the number of drinking days in participants.
Description
Number of drinking days and drinks per day/drinking day will be collected.
Time Frame
Throughout study duration (24 weeks)
Title
Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by measuring the proportion of heavy drinking days in participants.
Description
Percent of heavy drinking days (5+/4+ males/females)/very heavy drinking days (10+/8+ males/females) per week and per month will be collected.
Time Frame
Throughout study duration (24 weeks)
Title
Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by measuring the proportion of participants without heavy drinking days.
Description
Percent of subjects who are abstinent, percent of subjects with no heavy drinking days and percent of days abstinent will be collected.
Time Frame
Throughout study duration (24 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard Le Foll
Phone
416-535-8501
Ext
33111
Email
bernard.lefoll@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Kim
Phone
416-535-8501
Ext
32848
Email
esther.kim@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Le Foll
Organizational Affiliation
The Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard Le Foll, MD, PhD
Phone
416-535-8501
Ext
33111
Email
bernard.lefoll@camh.ca
12. IPD Sharing Statement
Learn more about this trial
Cytisine for Smoking Cessation
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