Center for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
NCT Number: NCT05729243
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Toronto, Ontario, M5S 2S1, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
A placebo identical in appearance to cytisine will be used
Time frame: Total duration of trial (24 weeks)
To assess the tolerability of cytisine
Time frame: Total duration of trial (24 weeks)
To assess the tolerability of cytisine
Time frame: Week 2 and week 4
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: Throughout study completion, up to 24 weeks.
Point-prevalence abstinence at each consecutive assessment point.
Time frame: This period will end at the end of treatment (day 25) or at final follow-up.
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 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: Throughout study completion, up to 24 weeks.
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 duration (24 weeks)
The Fagerstrom Test for Nicotine Dependence (FTND) will be used to assess physical dependence in participants.
Time frame: Throughout study duration (24 weeks)
The Minnesota Nicotine Withdrawal Scale (MNWS) will be used to assess nicotine withdrawal symptoms.
Time frame: Throughout study duration (24 weeks)
Tiffany Questionnaire of Smoking Urges (QSU) will be used to assess nicotine craving.
Time frame: Throughout study duration (24 weeks)
Anxiety will be measured through the General Anxiety Disorder-7 (GAD-7) questionnaire.
Time frame: Throughout study duration (24 weeks)
Mood will be measured by the Patient Health Questionnaire-9 (PHQ-9).
Time frame: Throughout study duration (24 weeks)
Quality of Life will be measured through the WHO Disability Assessment Schedule (WHODAS).
Time frame: Throughout study duration (24 weeks)
Number of drinking days and drinks per day/drinking day will be collected.
Time frame: Throughout study duration (24 weeks)
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)
Percent of subjects who are abstinent, percent of subjects with no heavy drinking days and percent of days abstinent will be collected.
Centre for Addiction and Mental Health
Other
Cytisine: Testing Its Potential as a Therapeutic Strategy for Smoking Cessation Among People With Concurrent Alcohol Use Disorder
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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