Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts

2014-07-23 21:11:38 | BioPortfolio


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.


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

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Tobacco Use Disorder


bupropion, varenicline, motivational emails


Centre for Addiction and Mental Health
M5T 1P7


Not yet recruiting


Centre for Addiction and Mental Health

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:11:38-0400

Clinical Trials [1392 Associated Clinical Trials listed on BioPortfolio]

Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

The objective of this proposal is to elucidate effects of bupropion SR + varenicline on smoking-cessation related processes in early abstinence using a human laboratory model. A within-su...

Varenicline and Bupropion for Smoking Cessation

This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase ...

Improving Varenicline Adherence and Outcomes in Homeless Smokers

the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Bupropion and Weight Control for Smoking Cessation - 1

The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.

Study of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation

The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit.

PubMed Articles [5464 Associated PubMed Articles listed on BioPortfolio]

Individual differences in responding to bupropion or varenicline in a preclinical model of nicotine self-administration vary according to individual demand for nicotine.

Bupropion and varenicline are the top two smoking cessation interventions that are marginally successful in increasing abstinence rates when compared to placebo. Although smokers vary in their history...

Predicting smoking abstinence with biological and self-report measures of adherence to varenicline: Impact on pharmacogenetic trial outcomes.

Adherence to pharmacotherapies for tobacco dependence, such as varenicline, is necessary for effective treatment. The relationship between varenicline adherence, determined by commonly used indirect (...

Severe bupropion XR abuse in a patient with long-standing bulimia nervosa and complex PTSD.

Although abuse of bupropion to achieve euphoria or a stimulant-like effect has been described in the literature, to our knowledge abuse of bupropion XR to control binge eating and reduce appetite by a...

Green tobacco sickness: Mecamylamine, varenicline, and nicotine vaccine as clinical research tools and potential therapeutics.

Green tobacco sickness occurs from transdermal absorption of chemicals from freshly harvested, green tobacco leaves. Signs and symptoms include nausea, vomiting, headache, and abdominal cramps. Preval...

Blockade of nicotinic acetylcholine receptor enhances the responsiveness to bupropion in the mouse forced swim test.

The objective of the present study is to investigate the role of α4, α5, α6 or β2 nAChR subunits in the antidepressant-like effect of bupropion. Adult male mice were treated with subcutaneous acut...

Medical and Biotech [MESH] Definitions

Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.

The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.

Use of TOBACCO (Nicotiana tabacum L) and TOBACCO PRODUCTS.

Inhaling and exhaling the smoke of tobacco or something similar to tobacco.

Items used to aid in ending a TOBACCO habit.

More From BioPortfolio on "Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts"

Quick Search


Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

Searches Linking to this Trial