Tobacco Use DisorderPhase 4NCT01023659
Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts
A Phase 4 study testing bupropion, varenicline and motivational emails in people with Tobacco Use Disorder and Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Bupropion and varenicline are indicated for smoking cessation. The objectives of this study are two-fold: (1) to explore the logistic feasibility of distributing bupropion and varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada and (2) to evaluate the real-world effectiveness of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Smoking, Smoking Cessation
- What is being tested?
- bupropion, varenicline and motivational emails
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 893 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female, at least 18 years of age, resident of Ontario, smoke at least 10 cigarettes per day, had smoked daily for at least the past 3 months, had smoked at least 100 cigarettes in their lifetime and intended to quit smoking in the next 30 days.
Who cannot join
- history of brain injury or seizure(s); pregnancy, lactation or risk of becoming pregnant; allergy or sensitivity to bupropion or varenicline; current use of monoamine oxidase inhibitors (MAOIs), thioridazine, varenicline or buproprion; severe liver impairment; or history of anorexia and /or bulimina.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.
Bupropion and varenicline are indicated for smoking cessation. The objectives of this study are two-fold: (1) to explore the logistic feasibility of distributing bupropion and varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will enroll via the study website, visit their physician to receive a prescription for bupropion or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison group. All participants will receive weekly motivational emails for 12 weeks. Abstinence measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of eligible participants who were able to confirm an appointment with a physician to receive the prescription will be also measured.
Read the detailed description
Bupropion and varenicline are effective pharmacotherapies for smoking cessation, but their population level impact is limited by a combination of factors. Both bupropion and varenicline are only available through prescription, however smoking cessation clinics are few in number and only about 25% of smokers receive information on smoking cessation aids from their healthcare provider. Mass distribution approaches, bypassing clinics and physicians, have been successful for nicotine replacement therapy in many jurisdictions, including Ontario. However, bupropion and varenicline have the potential to make a greater impact given their superior results from the clinical trials. Bupropion and varenicline present a unique challenge as they are prescribed medications, therefore we have proposed a variant of the mass distribution method to test whether it is practical to distribute them to a large number of people over a expansive geographic area (i.e., Ontario).
We hypothesize that engaging smokers with the opportunity to receive free bupropion or varenicline, to initiate an appointment with their physician to obtain a prescription that would be filled and mailed to the smoker from a central pharmacy would be a logistically feasible approach to reach high number of smokers from a wide geographic area. Our second hypothesis is that consistent with the results from clinical studies, in the general population varenicline would be associated with a higher abstinence rate than bupropion, and both varenicline and bupropion groups would achieve higher abstinence rates than those making quit attempts without any pharmacotherapy aid.
This is an open label, proof-of-concept study, wherein 2000 eligible participants will have the opportunity to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in conjunction with weekly motivational emails. Eligible participants will discuss with their doctor which of the two medications is appropriate for them to use as smoking cessation aid. It is also possible that the participant and his/her doctor may decide not to pursue smoking cessation using either of these medications. These participants will form a third intervention group, receiving only the weekly motivational emails. All participants will set a quit date of their choosing, but those receiving medication will set a quit date 7 days after starting the medication. The participants will enroll in the study via the study's website, at which time they will read the consent form, answer the eligibility questions and complete the baseline questionnaire. Data related to the outcome measures and adverse events will be collected at 4, 8 and 12 weeks after the start of treatment and at 6 and 12 months after the end of treatment.
- Conditions
- Tobacco Use Disorder, Smoking, Smoking Cessation
- Being tested
- bupropion, varenicline, motivational emails
- Keywords
- Smoking cessation, Bupropion, Varenicline, Population-level, Mass distribution, Drug Therapy
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropionDrug
Also called Zyban
bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
vareniclineDrug
Also called Champix
varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
motivational emailsBehavioural
brief motivational emails, sent weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bupropion + motivational emails | Active comparator | participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks. Receives: Drug: bupropion; Behavioral: motivational emails |
| Varenicline + motivational emails | Active comparator | participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks. Receives: Drug: varenicline; Behavioral: motivational emails |
| Motivational emails | Active comparator | participants receive weekly motivational emails for 12 weeks. Receives: Behavioral: motivational emails |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence of Abstinence
7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"
Measured: 6-month
Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician
Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed
Measured: End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Dr. Peter Selby, Centre for Addiction and Mental Health
- Investigators
- Peter Selby, MD, MHSc, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023659
- Sponsor's protocol ID
- 068/2009
- Status last verified
- Jan 2018
- First submitted
- 30 Nov 2009
- Last updated
- 24 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Selby P, Hussain S, Voci S, Zawertailo L. Empowering smokers with a web-assisted tobacco intervention to use prescription smoking cessation medications: a feasibility trial. Implement Sci. 2015 Oct 1;10:139. doi: 10.1186/s13012-015-0329-7.
PubMed 26429100
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.
- ClinicalTrials.gov ID
- NCT01023659
- Acronym / sponsor ID
- 068/2009
- Conditions
- Tobacco Use Disorder, Smoking, Smoking Cessation
- Keywords
- Smoking cessation, Bupropion, Varenicline, Population-level, Mass distribution, Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 15 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bupropion and varenicline are indicated for smoking cessation. The objectives of this study are two-fold: (1) to explore the logistic feasibility of distributing bupropion and varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will enroll via the study website, visit their physician to receive a prescription for bupropion or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison group. All participants will receive weekly motivational emails for 12 weeks. Abstinence measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of eligible participants who were able to confirm an appointment with a physician to receive the prescription will be also measured.
Detailed description
Bupropion and varenicline are effective pharmacotherapies for smoking cessation, but their population level impact is limited by a combination of factors. Both bupropion and varenicline are only available through prescription, however smoking cessation clinics are few in number and only about 25% of smokers receive information on smoking cessation aids from their healthcare provider. Mass distribution approaches, bypassing clinics and physicians, have been successful for nicotine replacement therapy in many jurisdictions, including Ontario. However, bupropion and varenicline have the potential to make a greater impact given their superior results from the clinical trials. Bupropion and varenicline present a unique challenge as they are prescribed medications, therefore we have proposed a variant of the mass distribution method to test whether it is practical to distribute them to a large number of people over a expansive geographic area (i.e., Ontario).
We hypothesize that engaging smokers with the opportunity to receive free bupropion or varenicline, to initiate an appointment with their physician to obtain a prescription that would be filled and mailed to the smoker from a central pharmacy would be a logistically feasible approach to reach high number of smokers from a wide geographic area. Our second hypothesis is that consistent with the results from clinical studies, in the general population varenicline would be associated with a higher abstinence rate than bupropion, and both varenicline and bupropion groups would achieve higher abstinence rates than those making quit attempts without any pharmacotherapy aid.
This is an open label, proof-of-concept study, wherein 2000 eligible participants will have the opportunity to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in conjunction with weekly motivational emails. Eligible participants will discuss with their doctor which of the two medications is appropriate for them to use as smoking cessation aid. It is also possible that the participant and his/her doctor may decide not to pursue smoking cessation using either of these medications. These participants will form a third intervention group, receiving only the weekly motivational emails. All participants will set a quit date of their choosing, but those receiving medication will set a quit date 7 days after starting the medication. The participants will enroll in the study via the study's website, at which time they will read the consent form, answer the eligibility questions and complete the baseline questionnaire. Data related to the outcome measures and adverse events will be collected at 4, 8 and 12 weeks after the start of treatment and at 6 and 12 months after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupropion + motivational emails | Active comparator | Drug: bupropion, Behavioral: motivational emailsparticipants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks. |
| Varenicline + motivational emails | Active comparator | Drug: varenicline, Behavioral: motivational emailsparticipants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks. |
| Motivational emails | Active comparator | Behavioral: motivational emailsparticipants receive weekly motivational emails for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or female, at least 18 years of age, resident of Ontario, smoke at least 10 cigarettes per day, had smoked daily for at least the past 3 months, had smoked at least 100 cigarettes in their lifetime and intended to quit smoking in the next 30 days.
Key exclusion criteria (1 listed)
- history of brain injury or seizure(s); pregnancy, lactation or risk of becoming pregnant; allergy or sensitivity to bupropion or varenicline; current use of monoamine oxidase inhibitors (MAOIs), thioridazine, varenicline or buproprion; severe liver impairment; or history of anorexia and /or bulimina.
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 |
|---|---|---|
| bupropionAlso: Zybanbupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks | Drug | Bupropion + motivational emails |
| vareniclineAlso: Champixvarenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks | Drug | Varenicline + motivational emails |
| motivational emailsbrief motivational emails, sent weekly for 12 weeks | Behavioural | Bupropion + motivational emails, Motivational emails, Varenicline + motivational emails |
Primary outcome
7-day Point Prevalence of Abstinence
Time frame: 6-month
7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"
Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician
Time frame: End of Treatment
Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26429100Selby P, Hussain S, Voci S, Zawertailo L. Empowering smokers with a web-assisted tobacco intervention to use prescription smoking cessation medications: a feasibility trial. Implement Sci. 2015 Oct 1;10:139. doi: 10.1186/s13012-015-0329-7.
- Individual participant dataSharing planned: No
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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.
Peter Selby, MD, MHSc 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 Phase 4 study testing bupropion, varenicline and motivational emails in people with Tobacco Use Disorder and Smoking, 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 1 inclusion and 1 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 24 Jan 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
7-day Point Prevalence of Abstinence (time frame: 6-month). The study lists 2 primary outcomes in all. 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 NCT01023659, which also lists 1 linked publication.
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 24 Jan 2018.