Cytisine for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Cytisine: Testing Its Potential as a Therapeutic Strategy for Smoking Cessation Among People With Concurrent Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729243
• Other study ID #: 054-2022
• Status: Recruiting
• Phase: Phase 4
• Start date: February 8, 2023
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Centre for Addiction and Mental Health
• Contact: Bernard Le Foll
• Phone: 416-535-8501
• Email: bernard.lefoll[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Drug:
• Cytisine
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.

Other:
• Placebo
A placebo identical in appearance to cytisine will be used

Locations

Country	Name	City	State
Canada	Center for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on anxiety.	Anxiety will be measured through the General Anxiety Disorder-7 (GAD-7) questionnaire.	Throughout study duration (24 weeks)
Other	Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on mood.	Mood will be measured by the Patient Health Questionnaire-9 (PHQ-9).	Throughout study duration (24 weeks)
Other	Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on Quality of Life.	Quality of Life will be measured through the WHO Disability Assessment Schedule (WHODAS).	Throughout study duration (24 weeks)
Other	Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by collecting the number of drinking days in participants.	Number of drinking days and drinks per day/drinking day will be collected.	Throughout study duration (24 weeks)
Other	Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by measuring the proportion of heavy drinking days in participants.	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.	Throughout study duration (24 weeks)
Other	Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by measuring the proportion of participants without heavy drinking days.	Percent of subjects who are abstinent, percent of subjects with no heavy drinking days and percent of days abstinent will be collected.	Throughout study duration (24 weeks)
Primary	Frequency and type of adverse events	To assess the tolerability of cytisine	Total duration of trial (24 weeks)
Primary	Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw	To assess the tolerability of cytisine	Total duration of trial (24 weeks)
Secondary	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).	Week 2 and week 4
Secondary	Repeated point-prevalence abstinence	Point-prevalence abstinence at each consecutive assessment point.	Throughout study completion, up to 24 weeks.
Secondary	Prolonged abstinence	Complete abstinence ("not even a puff") after an initial grace period; also known as sustained abstinence.	This period will end at the end of treatment (day 25) or at final follow-up.
Secondary	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).	This period will end at the end of treatment (day 25) or at final follow-up.
Secondary	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.	Throughout study completion, up to 24 weeks.
Secondary	Physical dependence to Nicotine in Participants	The Fagerstrom Test for Nicotine Dependence (FTND) will be used to assess physical dependence in participants.	Throughout study duration (24 weeks)
Secondary	Nicotine Withdrawal Symptoms in Participants	The Minnesota Nicotine Withdrawal Scale (MNWS) will be used to assess nicotine withdrawal symptoms.	Throughout study duration (24 weeks)
Secondary	Nicotine Craving in Participants	Tiffany Questionnaire of Smoking Urges (QSU) will be used to assess nicotine craving.	Throughout study duration (24 weeks)