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Alkaloid

Cytisine for Smoking Cessation

Phase 4

Recruiting

Led By Bernard Le Foll

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-65 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this period will end at the end of treatment (day 25) or at final follow-up.

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a drug to help people with alcohol use disorder quit smoking. #smokingcessation #alcoholud

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of cytisine are not listed here, common ones may include nausea, headache, dry mouth, and trouble sleeping. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this period will end at the end of treatment (day 25) or at final follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this period will end at the end of treatment (day 25) or at final follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this period will end at the end of treatment (day 25) or at final follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and type of adverse events

Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw

Secondary outcome measures

Continuous Abstinence

Nicotine Craving in Participants

Nicotine Withdrawal Symptoms in Participants

+5 more

Other outcome measures

Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on Quality of Life.

Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on anxiety.

Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by collecting the number of drinking days in participants.

+3 more

Side effects data

From 2019 Phase 2 trial • 254 Patients • NCT03709823

14%

Abnormal dreams

Insomnia

Nausea

Upper respiratory tract infection

Fatigue

Anxiety

Headache

100%

80%

60%

40%

20%

Study treatment Arm

3.0 mg Cytisine, Commercial Schedule

1.5 mg Cytisine, Commercial Schedule

Placebo, TID Schedule

1.5 mg Cytisine, TID Schedule

3.0 mg Cytisine, TID Schedule

Placebo, Commercial Schedule

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytisine

2017

Completed Phase 3

~1710

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,410 Total Patients Enrolled

25 Trials studying Tobacco Use Disorder

4,306 Patients Enrolled for Tobacco Use Disorder

Bernard Le FollPrincipal InvestigatorThe Centre for Addiction and Mental Health

1 Previous Clinical Trials

16 Total Patients Enrolled

Media Library

Cytisine (Alkaloid) Clinical Trial Eligibility Overview. Trial Name: NCT05729243 — Phase 4

Tobacco Use Disorder Research Study Groups: Cytisine, Placebo

Tobacco Use Disorder Clinical Trial 2023: Cytisine Highlights & Side Effects. Trial Name: NCT05729243 — Phase 4

Cytisine (Alkaloid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05729243 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals aged 80 and over qualify for this experiment?

"The minimum age of consent has been set at 18 while the upper threshold for enrollment is 65 years old, as stipulated in this trial's inclusion criteria."

Answered by AI

Has the FDA given its stamp of approval to Cytisine?

"Cytisine's safety has been proven in a Phase 4 trial, thus receiving the highest score of 3 for our team at Power."

Answered by AI

Are there opportunities for recruitment into this trial presently?

"Clinicaltrials.gov data affirms that this research is actively recruiting individuals, after it was initially posted on February 8th 2023 and more recently modified on April 4th of the same year."

Answered by AI

How many participants will be included in this trial?

"Affirmative. Clinicaltrials.gov records indicate that recruitment for this study, which was initially posted on February 8th 2023, is ongoing. It requires 48 participants from 1 medical site to participate in the trial."

Answered by AI

What are the projected results of this research?

"This 24-week trial is designed to measure the rate of patient retention, determined by analysing how many sessions were completed and which participants withdrew. Secondary objectives include measuring repeated point prevalence abstinence (no smoking during consecutive assessments), prolonged abstinence (total cessation after an initial leniency period) and protracted abstinence with lapses (several days of allowed smoking)."

Answered by AI

To what demographic does eligibility for this clinical trial extend?

"This trial is recruiting 48 individuals aged 18 to 65 who suffer from tobacco use disorder. Essential criteria for entry into the study include an assessment of TUD through a structured clinical interview, active AUD as indicated by a DSM-5 score, self-reported daily cigarette consumption in the past month and expired carbon monoxide measurement greater than 10ppm during screening, FTND55 score greater than 4, motivation to quit within 30 days (Contemplation Ladder56) score above 7 and voluntary written informed consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cytisine for Smoking Cessation

2023. "Cytisine for Smoking Cessation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05729243.

All > Smoking Cessation