Cytisine for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Overseen by Bernard Le Foll

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Centre for Addiction and Mental Health

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bernard Le Foll

Principal Investigator

The Centre for Addiction and Mental Health

Eligibility Criteria

This trial is for adults aged 18-65 who smoke daily, want to quit within the next month, and have a tobacco use disorder as well as an active alcohol use disorder. They must be willing to follow study rules and not have serious health issues like certain heart diseases, severe psychiatric conditions, or be pregnant.

Inclusion Criteria

Able to provide voluntary written informed consent

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

Exclusion Criteria

Enrolled in another study which would interfere with study procedures or represent a potential risk to the participant

I do not have any severe mental or physical health issues that would stop me from joining the trial.

Enrolled in another smoking cessation program

Treatment Details

Interventions

• Cytisine (Alkaloid)
• Placebo (Behavioural Intervention)

Trial Overview The trial is testing cytisine's ability to help people stop smoking compared with a placebo (a substance with no therapeutic effect). Participants will either receive cytisine or the placebo while their progress in quitting smoking is monitored.

Participant Groups

Group I: Cytisine Experimental Treatment 1 Intervention

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)

Group II: Placebo Placebo Group 1 Intervention

Placebo will be given following the same schedule as the Cytisine Arm.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Dr. Catherine Zahn

Centre for Addiction and Mental Health

Chief Executive Officer since 2009

MD, University of Toronto

Dr. James Graham

Centre for Addiction and Mental Health

Chief Medical Officer since 2024

PhD in Functional Neuroimaging