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Cytisine for Smoking Cessation

Tobacco Use Disorder | Smoking Cessation | Alcohol Use Disorder

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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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 to 65

Participation 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)

Study Location

Center for Addiction and Mental Health
Center for Addiction and Mental Health
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Bernard Le Foll, MD, PhD

[email protected]
416-535-8501
Study Sponsored By
Centre for Addiction and Mental Health
Participants Required
More Information
Study ID: NCT05729243