Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health Promotion & Sport
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01023659
First received: November 30, 2009
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Smoking
Smoking Cessation
Drug: bupropion
Drug: varenicline
Behavioral: motivational emails
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • 7-day Point Prevalence of Abstinence [ Time Frame: 6-month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed


Enrollment: 923
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupropion + motivational emails
participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
Drug: bupropion
bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
Other Name: Zyban
Behavioral: motivational emails
brief motivational emails, sent weekly for 12 weeks
Active Comparator: Varenicline + motivational emails
participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
Drug: varenicline
varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
Other Name: Champix
Behavioral: motivational emails
brief motivational emails, sent weekly for 12 weeks
Active Comparator: Motivational emails
participants receive weekly motivational emails for 12 weeks.
Behavioral: motivational emails
brief motivational emails, sent weekly for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male or female, at least 18 years of age, resident of Ontario, smoke 10 or more cigarettes, daily smoker for at least the past 3 months, intend to quit in the next 30 days.

Exclusion Criteria:

  • history of eating disorder, brain injury, seizure disorder, pregnancy, lactation, or at risk of becoming pregnant, allergy or sensitivity to bupropion or varenicline, concomitant use of monoamine oxidase inhibitors, thioridazine or Wellbutrin or other medication containing bupropion hydrochloride.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023659

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1P7
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Ministry of Health Promotion & Sport
Investigators
Principal Investigator: Peter Selby, MD, MHSc Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Peter Selby, Clinical Director, Addictions Program, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01023659     History of Changes
Other Study ID Numbers: 068/2009
Study First Received: November 30, 2009
Results First Received: February 14, 2013
Last Updated: February 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre for Addiction and Mental Health:
Smoking cessation
Bupropion
Varenicline
Population-level
Mass distribution
Drug Therapy

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Bupropion
Varenicline
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents

ClinicalTrials.gov processed this record on April 17, 2014