Cytisine for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Overseen byBernard Le Foll

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

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.

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

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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

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Treatment Details

Interventions

Cytisine (Alkaloid)
Placebo (Behavioural Intervention)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CytisineExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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