Cytisine for Smoking Cessation

Last updated: February 25, 2026
Sponsor: Centre for Addiction and Mental Health
Overall Status: Completed

Phase

4

Condition

Alcohol Use Disorder

Alcohol Dependence

Addictions

Treatment

Cytisine

Placebo

Clinical Study ID

NCT05729243
054-2022
  • Ages 18-65
  • All Genders

Study 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

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

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 apotential risk to the participant

  • Have a serious unstable psychiatric or medical condition preventing participation inthe trial. This includes some forms of schizophrenia, ischemic heart disease, heartfailure, 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, andgastroesophageal reflux disease (GERD)

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Cytisine
Phase: 4
Study Start date:
February 08, 2023
Estimated Completion Date:
December 12, 2025

Connect with a study center

  • Center for Addiction and Mental Health

    Toronto, Ontario M5S 2S1
    Canada

    Site Not Available

  • Center for Addiction and Mental Health

    Toronto 6167865, Ontario 6093943 M5S 2S1
    Canada

    Site Not Available

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