Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.

Conditions
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Tobacco Use Disorder, Smoking, Smoking Cessation

Intervention / Treatment
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* Drug: bupropion
* Drug: varenicline
* Behavioral: motivational emails


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupropion + motivational emails<br>participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks. | Drug: bupropion<br>* bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks<br>* Other names: Zyban;Behavioral: motivational emails<br>* brief motivational emails, sent weekly for 12 weeks<br>|
| Active Comparator: Varenicline + motivational emails<br>participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks. | Drug: varenicline<br>* varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks<br>* Other names: Champix;Behavioral: motivational emails<br>* brief motivational emails, sent weekly for 12 weeks<br>|
| Active Comparator: Motivational emails<br>participants receive weekly motivational emails for 12 weeks. | Behavioral: motivational emails<br>* brief motivational emails, sent weekly for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 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 | End of Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Bupropion, Varenicline, Population-level, Mass distribution, Drug Therapy