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Plant-based medication

Cytisine vs Nicotine Replacement for Smoking Cessation (CYTvsNRT+ Trial)

N/A

Waitlist Available

Led By Bob Reid, PhD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 25-day follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a plant-based pill called Cytisine to help smokers with heart disease quit smoking. The pill makes cigarettes less enjoyable and reduces cravings. The study will see which method works better for people who have tried to quit smoking before. Cytisine is a low-cost, plant-based alkaloid that has been used as a smoking cessation aid in Eastern Europe for 50 years.

Eligible Conditions

Coronary Artery Disease
Smoking Cessation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 25-day follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 25-day follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 25-day 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

Feasibility of study

Secondary study objectives

Arterial Stiffness

Attrition

Cigarette consumption

+1 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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CytisineExperimental Treatment1 Intervention

Cravv™ (Zpharm, Waterloo) is a natural health product licensed by Health Canada to assist with smoking cessation; each oral capsule contains 1.5mg of cytisine. The dosing is as follows: 6 capsules daily for the first 3 days; 5 capsules daily for days 4-12; 4 capsules daily for days 13-16; 3 capsules daily for days 17-20; and 1-2 capsules daily for days 21-25.

Group II: NRT+Active Control2 Interventions

The Nicoderm® patch plus Nicorette® Lozenge will be provided to participants in the combination NRT group. Participants smoking less than 15 cigarettes per day will be provided with 14 mg patches while those smoking 15 or more cigarettes per day will receive 21 mg patches. Participants will be told to apply a new patch each morning. Participants will be instructed to use the lozenges as needed (up to 15 per day) to overcome nicotine cravings. Lozenges are available in both 2mg and 4mg strengths. For those who are smoking less than 15 cigarettes per day, they will be given the 2mg strength. For those who are smoking 15 or more cigarettes per day, they will receive the 4mg strength.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytisine

2017

Completed Phase 4

~3830

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