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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

Must not have

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)

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

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Continuous Abstinence

Nicotine Craving in Participants

Nicotine Withdrawal Symptoms in Participants

+5 more

Other study objectives

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

Fatigue

Upper respiratory tract infection

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 4

~3020

0 / 2Eligibility criteria met