Your session is about to expire
← Back to Search
Plant-based medication
Cytisine vs Nicotine Replacement for Smoking Cessation (CYTvsNRT+ Trial)
N/A
Waitlist Available
Led By Andrew Pipe, MD
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
Patient is enrolled in UOHI's Quit Smoking Program
Patient has relapsed to daily smoking ≥10 cigarettes per day within 90 days of discharge from UOHI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 25-day follow-up
Awards & highlights
CYTvsNRT+ Trial Summary
This trial will test whether a plant-based medication called Cytisine is more effective than conventional nicotine replacement therapy in helping smokers with cardiovascular disease who have failed to quit using conventional methods.
Eligible Conditions
- Smoking Cessation
- Coronary Artery Disease
CYTvsNRT+ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are currently involved in the UOHI's program to quit smoking.
Select...
You started smoking again, and you smoke at least 10 cigarettes per day within 90 days of leaving the UOHI.
Select...
You smoke at least 10 cigarettes per day.
CYTvsNRT+ Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of study
Secondary outcome measures
Arterial Stiffness
Attrition
Cigarette consumption
+1 moreSide effects data
From 2019 Phase 2 trial • 254 Patients • NCT0370982314%
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
CYTvsNRT+ 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
188 Previous Clinical Trials
92,423 Total Patients Enrolled
Andrew Pipe, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
8 Previous Clinical Trials
1,796 Total Patients Enrolled
Bob Reid, PhDPrincipal InvestigatorOttawa Heart Institute Research Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used certain types of medications or vaping devices for quitting smoking in the past 15 days.You are currently involved in the UOHI's program to quit smoking.You started smoking again, and you smoke at least 10 cigarettes per day within 90 days of leaving the UOHI.You smoke at least 10 cigarettes per day.
Research Study Groups:
This trial has the following groups:- Group 1: NRT+
- Group 2: Cytisine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any availability for participants in this investigation?
"Affirmative. According to clinicaltrials.gov, this research study is currently enrolling subjects; it was initially published on March 14th 2022 and most recently modified on April 29th 2022. The experiment requires 60 test subjects from a single site."
Answered by AI
What is the sample size of this research study?
"That is correct. According to the records on clinicaltrials.gov, this medical study commenced its recruitment process on March 14th 2022 and was last updated a month later. The trial requires 60 participants from 1 site in total."
Answered by AI
Did any prior research include the use of Cytisine?
"Currently, 72 trials related to Cytisine are ongoing with 6 reaching the final stage of clinical testing. Most of these studies are hosted in Greenville, South carolina but 204 other locations have also been enlisted for this research initiative."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger