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Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts

NCT01023659 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 893

Last updated 2018-01-24

Study results available
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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 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.

Conditions

  • Tobacco Use Disorder
  • Smoking
  • Smoking Cessation

Interventions

DRUG

bupropion

bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks

DRUG

varenicline

varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks

BEHAVIORAL

motivational emails

brief motivational emails, sent weekly for 12 weeks

Sponsors & Collaborators

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Peter Selby, MD, MHSc · Centre for Addiction and Mental Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01023659 on ClinicalTrials.gov