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Cytisine Compared to Combination NRT in Relapsed Smokers (CYTvsNRT+)

Primary Purpose

Smoking Cessation, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cytisine
Nicoderm C-Q Transdermal Product
Nicorette Lozenge Product
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Tobacco, Relapse prevention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is enrolled in UOHI's Quit Smoking Program;
  2. Patient has relapsed to daily smoking ≥10 cigarettes per day within 90 days of discharge from UOHI;
  3. Patient is currently smoking ≥10 cigarettes per day.

Exclusion Criteria:

  1. Patient has used NRT, cytisine, varenicline, bupropion or a nicotine-containing vaping device within in the past 15 days;
  2. Patient is unavailable to come to UOHI for assessments;
  3. Patient is unable to provide informed consent;
  4. Patient is unable to comprehend the intervention instructions (in the opinion of qualified investigators)

Sites / Locations

  • University of Ottawa Heart Insitute - Prevention and Wellness CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cytisine

NRT+

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of study
will be feasible to recruit 10 relapsed smokers with CHD per month to a study of cytisine vs. combination NRT

Secondary Outcome Measures

Treatment completion
Participants will complete at least 70% of their prescribed treatment
Attrition
There will be less than 5% attrition over a 25-d treatment period
Cigarette consumption
Cigarette consumption will drop by 5 cigs/d more in the cytisine group compared to the combination NRT group by the end of the 25-d treatment period
Arterial Stiffness
Arterial stiffness, as measured by pulse wave velocity, will improve in smokers who are able to achieve complete abstinence (i.e. smoking zero cigarettes per day).

Full Information

First Posted
February 21, 2020
Last Updated
May 5, 2023
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04286295
Brief Title
Cytisine Compared to Combination NRT in Relapsed Smokers
Acronym
CYTvsNRT+
Official Title
Pilot RCT of Cytisine Compared to Combination Nicotine Replacement Therapy to Reduce Cigarette Consumption in Relapsed Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cigarette smoking causes cardiovascular disease (CVD) yet many smokers with CVD are unable to quit despite strong desire to do so. Within 90 days of discharge, about 30% of smokers have returned to daily smoking and almost 60% have relapsed by 1 year. Patients with CVD who resume smoking are more likely to experience new events (e.g. heart attack or stroke) or die. New approaches are required. A new type of cessation product is a plant-based medication called Cytisine. Cytisine is taken orally over 25 days and reduces the pleasurable sensations that smokers get from cigarettes and reduces withdrawal symptoms. The primary research question is whether or not it is feasible to conduct a large-scale trial of the effectiveness of this product compared to conventional nicotine replacement therapy in smokers who have failed to quit using conventional methods. To determine feasibility, a pilot study will be conducted of sixty smokers (30 men, 30 women) with CVD who have been treated for smoking cessation but have relapsed within 90 days of discharge. Participants will complete a baseline assessment and will be randomly assigned to either the combination nicotine replacement therapy group (patch plus lozenge) or cytisine group. Participants will be treated for 25 days and then will return to UOHI so adherence to treatment and smoking status can be assessed. Feasibility of the larger trial will be based on: the recruitment rates; adherence to assigned treatments; dropout rates; and differences in 25-day quit rates between groups.
Detailed Description
Cigarette smoking is a causative factor in the development of coronary heart disease (CHD), and is the most dangerous form of tobacco use. Effective treatments for smoking cessation exist but relapse to cigarette smoking is common, principally due to nicotine addiction and related symptoms of withdrawal. Little is known about how best to support smokers who have relapsed in subsequent attempts to change their smoking behavior. One emerging treatment has features that might make it appealing to smokers and may be effective in the setting of recent relapse: cytisine. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central/eastern Europe. Cytisine is a partial agonist of nicotinic acetylcholine receptors (nAChRs), which is central to the effect of nicotine on the reward pathway. Cytisine acts by reducing the rewarding effect of nicotine and attenuating nicotine withdrawal symptoms. A recent review concluded that cytisine is the most promising future smoking cessation treatment. Cytisine is inexpensive to produce and is currently priced much lower than other cessation medications. It is well-tolerated by smokers and requires a shorter treatment period (i.e. 25 days) than conventional treatments. Because it is plant-based, cytisine may be attractive for smokers who prefer 'natural' medicines. Numerous placebo-controlled studies have demonstrated the safety and efficacy of cytisine. One high-quality pragmatic non-inferiority trial (n = 1310) found that cytisine was superior to nicotine replacement therapy (NRT) in improving self-reported continuous abstinence rates at 1 week, and 1, 2 and 6 months when both groups received minimal behavioural support. In Canada, cytisine is marketed as the natural health product Cravv™. The long-term goal is to conduct a definitive, large-scale randomized controlled trial (RCT) of the efficacy of cytisine compared to conventional treatment (i.e. combination NRT) for smoking cessation among smokers who have relapsed to smoking following hospitalization for a CHD-related event. Prior to conducting a larger, definitive RCT there is a need to conduct a pilot study to better understand the potential feasibility of such a trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Coronary Artery Disease
Keywords
Tobacco, Relapse prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cytisine
Arm Type
Experimental
Arm Description
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.
Arm Title
NRT+
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cytisine
Intervention Description
Cytisine is a plant-based smoking cessation medication. Cytisine acts by reducing the rewarding effect of nicotine and attenuating nicotine withdrawal symptoms. A recent review concluded that cytisine is the most promising future smoking cessation treatment. Cytisine is inexpensive to produce and is currently priced much lower than other cessation medications. It is well-tolerated by smokers and requires a shorter treatment period than conventional treatments. Because it is plant-based, cytisine may be attractive for smokers who prefer 'natural' medicines. Numerous placebo-controlled studies have demonstrated the safety and efficacy of cytisine. One high-quality pragmatic non-inferiority trial (n = 1310) found that cytisine was superior to nicotine replacement therapy (NRT) in improving self-reported continuous abstinence rates at 1 week, and 1, 2 and 6 months when both groups received minimal behavioural support.
Intervention Type
Drug
Intervention Name(s)
Nicoderm C-Q Transdermal Product
Other Intervention Name(s)
NRT+
Intervention Description
The Nicoderm® patch plus Nicorette® Lozenge will be provided to participants in the combination NRT group. Participants will be instructed to apply a new patch each day. They will continue to wear patches for 25 days.
Intervention Type
Drug
Intervention Name(s)
Nicorette Lozenge Product
Intervention Description
Participants in the NRT group will receive Nicorette Lozenges to use during their 25-day quit attempt. They will receive enough lozenges to last for the 25-day treatment period.
Primary Outcome Measure Information:
Title
Feasibility of study
Description
will be feasible to recruit 10 relapsed smokers with CHD per month to a study of cytisine vs. combination NRT
Time Frame
Baseline to 25-day follow-up
Secondary Outcome Measure Information:
Title
Treatment completion
Description
Participants will complete at least 70% of their prescribed treatment
Time Frame
Baseline to 25-day follow-up
Title
Attrition
Description
There will be less than 5% attrition over a 25-d treatment period
Time Frame
Baseline to 25-day follow-up
Title
Cigarette consumption
Description
Cigarette consumption will drop by 5 cigs/d more in the cytisine group compared to the combination NRT group by the end of the 25-d treatment period
Time Frame
Baseline to 25-day follow-up
Title
Arterial Stiffness
Description
Arterial stiffness, as measured by pulse wave velocity, will improve in smokers who are able to achieve complete abstinence (i.e. smoking zero cigarettes per day).
Time Frame
Baseline to 25-day follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Patient is currently smoking ≥10 cigarettes per day. Exclusion Criteria: Patient has used NRT, cytisine, varenicline, bupropion or a nicotine-containing vaping device within in the past 15 days; Patient is unavailable to come to UOHI for assessments; Patient is unable to provide informed consent; Patient is unable to comprehend the intervention instructions (in the opinion of qualified investigators)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Baldwin
Phone
613-696-7000
Ext
14377
Email
AsBaldwin@ottawaheart.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Evyanne Wooding
Phone
613-696-7000
Ext
17596
Email
ewooding@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Pipe, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Insitute - Prevention and Wellness Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Baldwin
Phone
613-696-7000
Ext
14377
Email
asbaldwin@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Evyanne Quirouette
Phone
613-696-7000
Ext
17596
Email
ewooding@ottawaheart.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a pilot study so datasets will not be shared until a written request is submitted to the PI.

Learn more about this trial

Cytisine Compared to Combination NRT in Relapsed Smokers

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