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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

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
  • Smoking Cessation
  • Coronary Artery Disease

Timeline

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
8%
Insomnia
6%
Nausea
4%
Upper respiratory tract infection
4%
Fatigue
2%
Anxiety
2%
Headache
100%
80%
60%
40%
20%
0%
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
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 3
~1710

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
193 Previous Clinical Trials
92,879 Total Patients Enrolled
Bob Reid, PhDPrincipal InvestigatorOttawa Heart Institute Research Corporation
Andrew Pipe, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
8 Previous Clinical Trials
1,796 Total Patients Enrolled

Media Library

Cytisine (Plant-based medication) Clinical Trial Eligibility Overview. Trial Name: NCT04286295 — N/A
Smoking Cessation Research Study Groups: NRT+, Cytisine
Smoking Cessation Clinical Trial 2023: Cytisine Highlights & Side Effects. Trial Name: NCT04286295 — N/A
Cytisine (Plant-based medication) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04286295 — N/A
~4 spots leftby Sep 2025
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