Tobacco Use DisorderMATCHNCT02146911
The MATCH (Medication Aids for Tobacco Cessation and Health) Study
A study testing Bupropion, Varenicline and Weekly Motivational Emails in people with Tobacco Use Disorder and Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline are available to help smokers quit but there are not widely used. The primary objective of this study is to evaluate the real-world long-term effectiveness of of bupropion and varenicline treatment in a community sample of… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Tobacco Use Disorder, Nicotine Dependence
- What is being tested?
- Bupropion, Varenicline and Weekly Motivational Emails
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 968 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2014to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 19 years of age
- Smoking at least 10 cigarettes per day
- Smoked daily for at least the past year
- Have an intention of quit smoking in the next 30 days.
Who cannot join
- History of psychotic disorder or eating disorder
- Brain injury
- Seizure disorder
- Pregnancy, lactation, or at risk of becoming pregnant
- Allergy or sensitivity to bupropion or varenicline
- Taking monoamine oxidase inhibitors (anti-depressants), thioridazine or Wellbutrin or other medication containing bupropion hydrochloride.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Addiction and Mental Health, Nicotine Dependence Clinic
Toronto, Ontario, M5T 1P7
About this study
Official title: Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation
Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline are available to help smokers quit but there are not widely used. The primary objective of this study is to evaluate the real-world long-term effectiveness of of bupropion and varenicline treatment in a community sample of smokers interested in quitting. The investigators hypothesize that varenicline treatment will result in higher quit rates at end of treatment and at one year after treatment compared to bupropion. Smoking status will be biochemically confirmed at various time points using salivary cotinine measures. Furthermore, since 50% of the variation in quit success is genetically determined, and the effectiveness of different cessation medication may differ considerably in sub-groups of smokers carrying certain genetic variants, the investigators will collect saliva samples from consenting participants to evaluate the moderating effect of genetics on treatment response.
Read the detailed description
Only a fraction of smokers receive information about effective prescription-only smoking pharmacotherapies, bupropion and varenicline. Moreover, studies have demonstrated variable smoking cessation treatment outcomes correlate with individuals' genotypes and phenotypes. Mass distribution approaches, bypassing clinics and physicians, have been successful for nicotine replacement therapy. The primary objective of this study is to evaluate the real-world long-term effectiveness of mailed bupropion and varenicline treatment in a sample of interested smokers, utilizing web-based recruitment and follow-up. As part of the Genetics Sub-study, the pharmacogenetics of these smoking cessation medications is investigated. This is an open label study, wherein eligible participants will be randomized to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in conjunction with weekly motivational emails. Participants will spend approximately 20-30 minutes enrolling in the study through the study's website. During this time, they will read the consent form, answer the eligibility questions and complete the baseline questionnaire. Eligible participants are then asked if they are interested to participate in the Genetics Sub-study. Those who provide separate consent for the genetics component will complete additional questionnaires online (Between Facets and Domains Personality Test) and will be mailed a kit to provide a saliva sample. After successful completion of baseline questionnaire through the study website, eligible participants will be emailed a Letter to Doctor and a Standard Script to take to their doctor. Then, they will attend an appointment with their physician to discuss with their doctor whether the medication they have been assigned to is appropriate for them to use as smoking cessation aid. It is possible that the participant and his/her doctor will decide not to pursue smoking cessation using the assigned medication. These participants will still receive the weekly motivational emails and will be followed up at all time points, but they will not be included in the main data analysis. If the doctor believes that it is appropriate for the participants to take the assign medication, he/she will need to sign the Standard Script and fax it to the study contract pharmacy. Once the fax is received by the pharmacy, they will call the participants for a brief counseling. Then, they will fill the prescription and mail the medication to you free of charge. All participants will set a quit date of their choosing, but will start the medication 7 days prior to their target quit date. Data related to the outcome measures and adverse events will be collected at 4, 8 and 12, 26 and 52 weeks after the start of treatment in order to assess and compare both point prevalent and continuous abstinence effects of the two treatment interventions. Smoking status will be biochemically confirmed at baseline and at 26th and 52nd weeks following start of treatment using salivary cotinine measures. Medication compliance is assessed by self-report measures as part of the follow-up questionnaire. Compliance is also biochemically confirmed at 4 weeks following start of treatment.
- Conditions
- Tobacco Use Disorder, Nicotine Dependence
- Being tested
- Bupropion, Varenicline, Weekly Motivational Emails
- Keywords
- Smoking Cessation Medication, Smoking Treatment, Tobacco Treatment, Quitting Smoking, Bupropion, Varenicline, Efficacy, Pharmacogenetics of Smoking Treatment, Genetics analysis, Smoking Personality, Dependence, Addiction, Cigarettes, Primary Care Physicians, Biochemical Confirmation
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
VareniclineDrug
Weekly Motivational EmailsBehavioural
The e-mails will include tips on several things other than the medications that participants can do to help them quit smoking. The contents of the emails will vary from week to week. The e-mails will provide tips on ways to create an atmosphere that promotes quitting and staying abstinence. They will also include recommendations on how to address issues with withdrawal symptoms and cravings. In addition, they will provide positive motivational messages by stating facts on benefits of quitting smoking.
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Experimental | Bupropion hydrochloride SR, Sandoz Canada, Boucherville, Quebec. Dispense for 12 weeks. One tablet (150mg) once daily for first three days, then twice daily for the remainder of 12 weeks. Receives: Drug: Bupropion; Behavioral: Weekly Motivational Emails |
| Varenicline | Experimental | Varenicline tartrate (Champix®), Pfizer Canada Inc., Kirkland, Quebec. Dispense for 12 weeks. One tablet (0.5mg) once daily for first three days, then one tablet (0.5 mg) twice daily for next four days, then 1 mg (one 1mg tablet or two 0.5mg tablets) twice daily for the remainder of 12 weeks. Receives: Drug: Varenicline; Behavioral: Weekly Motivational Emails |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in smoking status over time
Related to effectiveness of smoking cessation intervention, The 7-day point prevalence abstinent rate is defined as not having smoked, even a puff, over the previous seven days.
Measured: At 12, 26, and 52 weeks following start of treatment
Secondary outcomes (2)
Pre-post Decisional Balance Scores
Related to physician practice changes after being approached by their patients about smoking cessation medications and being informed about the study.
Measured: upon first patient enrolled and 1 month following last patient enrolled
Continuous Abstinence
A measure of long-term smoking cessation and time to relapse.
Measured: 12, 26 and 52 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study start1 May 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Global Research Awards for Nicotine Dependence (GRAND)
- Responsible party
- Principal investigator, Laurie Zawertailo, Centre for Addiction and Mental Health
- Investigators
- Laurie Zawertailo, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146911
- Sponsor's protocol ID
- 200/2012
- Acronym
- MATCH
- Status last verified
- Jan 2017
- First submitted
- 20 May 2014
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang H, Mansoursadeghi-Gilan T, Hussain S, Veldhuizen S, Le Foll B, Selby P, Zawertailo L. Evaluating the effectiveness of bupropion and varenicline for smoking cessation using an internet-based delivery system: A pragmatic randomized controlled trial (MATCH study). Drug Alcohol Depend. 2022 Mar 1;232:109312. doi: 10.1016/j.drugalcdep.2022.109312. Epub 2022 Feb 9.
PubMed 35151504Zawertailo L, Mansoursadeghi-Gilan T, Zhang H, Hussain S, Le Foll B, Selby P. Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 18;7(10):e10826. doi: 10.2196/10826.
PubMed 30341043
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation
- ClinicalTrials.gov ID
- NCT02146911
- Acronym / sponsor ID
- MATCH / 200/2012
- Conditions
- Tobacco Use Disorder, Nicotine Dependence
- Keywords
- Smoking Cessation Medication, Smoking Treatment, Tobacco Treatment, Quitting Smoking, Bupropion, Varenicline, Efficacy, Pharmacogenetics of Smoking Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Global Research Awards for Nicotine Dependence (GRAND)
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline are available to help smokers quit but there are not widely used. The primary objective of this study is to evaluate the real-world long-term effectiveness of of bupropion and varenicline treatment in a community sample of smokers interested in quitting. The investigators hypothesize that varenicline treatment will result in higher quit rates at end of treatment and at one year after treatment compared to bupropion. Smoking status will be biochemically confirmed at various time points using salivary cotinine measures. Furthermore, since 50% of the variation in quit success is genetically determined, and the effectiveness of different cessation medication may differ considerably in sub-groups of smokers carrying certain genetic variants, the investigators will collect saliva samples from consenting participants to evaluate the moderating effect of genetics on treatment response.
Detailed description
Only a fraction of smokers receive information about effective prescription-only smoking pharmacotherapies, bupropion and varenicline. Moreover, studies have demonstrated variable smoking cessation treatment outcomes correlate with individuals' genotypes and phenotypes. Mass distribution approaches, bypassing clinics and physicians, have been successful for nicotine replacement therapy. The primary objective of this study is to evaluate the real-world long-term effectiveness of mailed bupropion and varenicline treatment in a sample of interested smokers, utilizing web-based recruitment and follow-up. As part of the Genetics Sub-study, the pharmacogenetics of these smoking cessation medications is investigated. This is an open label study, wherein eligible participants will be randomized to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in conjunction with weekly motivational emails. Participants will spend approximately 20-30 minutes enrolling in the study through the study's website. During this time, they will read the consent form, answer the eligibility questions and complete the baseline questionnaire. Eligible participants are then asked if they are interested to participate in the Genetics Sub-study. Those who provide separate consent for the genetics component will complete additional questionnaires online (Between Facets and Domains Personality Test) and will be mailed a kit to provide a saliva sample. After successful completion of baseline questionnaire through the study website, eligible participants will be emailed a Letter to Doctor and a Standard Script to take to their doctor. Then, they will attend an appointment with their physician to discuss with their doctor whether the medication they have been assigned to is appropriate for them to use as smoking cessation aid. It is possible that the participant and his/her doctor will decide not to pursue smoking cessation using the assigned medication. These participants will still receive the weekly motivational emails and will be followed up at all time points, but they will not be included in the main data analysis. If the doctor believes that it is appropriate for the participants to take the assign medication, he/she will need to sign the Standard Script and fax it to the study contract pharmacy. Once the fax is received by the pharmacy, they will call the participants for a brief counseling. Then, they will fill the prescription and mail the medication to you free of charge. All participants will set a quit date of their choosing, but will start the medication 7 days prior to their target quit date. Data related to the outcome measures and adverse events will be collected at 4, 8 and 12, 26 and 52 weeks after the start of treatment in order to assess and compare both point prevalent and continuous abstinence effects of the two treatment interventions. Smoking status will be biochemically confirmed at baseline and at 26th and 52nd weeks following start of treatment using salivary cotinine measures. Medication compliance is assessed by self-report measures as part of the follow-up questionnaire. Compliance is also biochemically confirmed at 4 weeks following start of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Experimental | Drug: Bupropion, Behavioral: Weekly Motivational EmailsBupropion hydrochloride SR, Sandoz Canada, Boucherville, Quebec. Dispense for 12 weeks. One tablet (150mg) once daily for first three days, then twice daily for the remainder of 12 weeks. |
| Varenicline | Experimental | Drug: Varenicline, Behavioral: Weekly Motivational EmailsVarenicline tartrate (Champix®), Pfizer Canada Inc., Kirkland, Quebec. Dispense for 12 weeks. One tablet (0.5mg) once daily for first three days, then one tablet (0.5 mg) twice daily for next four days, then 1 mg (one 1mg tablet or two 0.5mg tablets) twice daily for the remainder of 12 weeks. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 19 years of age
- Smoking at least 10 cigarettes per day
- Smoked daily for at least the past year
- Have an intention of quit smoking in the next 30 days.
Key exclusion criteria (6 listed)
- History of psychotic disorder or eating disorder
- Brain injury
- Seizure disorder
- Pregnancy, lactation, or at risk of becoming pregnant
- Allergy or sensitivity to bupropion or varenicline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion | Drug | Bupropion |
| Varenicline | Drug | Varenicline |
| Weekly Motivational EmailsThe e-mails will include tips on several things other than the medications that participants can do to help them quit smoking. The contents of the emails will vary from week to week. The e-mails will provide tips on ways to create an atmosphere that promotes quitting and staying abstinence. They will also include recommendations on how to address issues with withdrawal symptoms and cravings. In addition, they will provide positive motivational messages by stating facts on benefits of quitting smoking. | Behavioural | Bupropion, Varenicline |
Primary outcome
Change in smoking status over time
Time frame: At 12, 26, and 52 weeks following start of treatment
Related to effectiveness of smoking cessation intervention, The 7-day point prevalence abstinent rate is defined as not having smoked, even a puff, over the previous seven days.
2 secondary outcomes
Pre-post Decisional Balance Scores
Time frame: upon first patient enrolled and 1 month following last patient enrolled
Continuous Abstinence
Time frame: 12, 26 and 52 weeks after start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Derived from this study: PubMed 35151504Zhang H, Mansoursadeghi-Gilan T, Hussain S, Veldhuizen S, Le Foll B, Selby P, Zawertailo L. Evaluating the effectiveness of bupropion and varenicline for smoking cessation using an internet-based delivery system: A pragmatic randomized controlled trial (MATCH study). Drug Alcohol Depend. 2022 Mar 1;232:109312. doi: 10.1016/j.drugalcdep.2022.109312. Epub 2022 Feb 9.
- Derived from this study: PubMed 30341043Zawertailo L, Mansoursadeghi-Gilan T, Zhang H, Hussain S, Le Foll B, Selby P. Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 18;7(10):e10826. doi: 10.2196/10826.
- Link Text: Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Zawertailo, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion, Varenicline and Weekly Motivational Emails in people with Tobacco Use Disorder and Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in smoking status over time (time frame: At 12, 26, and 52 weeks following start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02146911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.