Official Title: “The STOP Study: Real World Effectiveness of Zyban Treatment in a Clinical Population”

Despite the significant health, social and economic costs of cigarette smoking, 17% of Ontarians still currently smoke. Use of smoking cessation pharmacotherapy such as Zyban (bupropion HCl) has been shown to double quit rates but such medications are under-utilized by smokers attempting to quit. It has been suggested that the high price of pharmacotherapy may act as a barrier to accessing such treatment.The main objective of this study is to evaluate the methods and effectiveness of providing smokers who want to quit with 8 weeks of free Zyban in combination with smoking cessation counselling through family health teams and community health centres across the province.

Hypothesis: Ontario smokers who receive 8-weeks of free bupropion in combination with brief counselling will have higher smoking cessation rates than the standard population cessation rates.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: April 2011

Intervention(s) in this Clinical Trial

• Drug: bupropion HCl
  • 150mg BID for up to 8 weeks
• Behavioral: smoking cessation counselling
  • brief individual counselling sessions focusing on smoking cessation and relapse prevention

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Zyban

Primary Measures

• 7-day point prevalence of smoking abstinence
  • Time Frame: End of Treatment (8 weeks after Zyban start date), 6 and 12 months after end of treatment
    Safety Issue?: No

Secondary Measures

• Serious quit attempt (at least 24 hours of abstinence)
  • Time Frame: End of Treatment (8 weeks after Zyban start date), 6 and 12 months after end of treatment
    Safety Issue?: No

Inclusion Criteria:

• Ontario resident
• 18 years of age or older
• Current daily cigarette smoker who smokes 10 or more cigarettes per day and has smoked > 100 cigarettes in their lifetime
• Want to quit smoking cigarettes within 30 days of assessment
• Willingness and capacity to give written informed consent and to comply with study protocol

Exclusion Criteria:

• Enrollment in any of the STOP Study NRT models in the past 6 months
• Currently receiving Wellbutrin SR or any medication containing bupropion hydrochloride
• Current seizure disorder or history of seizures
• Current or prior diagnosis of bulimia or anorexia nervosa
• Current diagnosis of bipolar disorder
• History of head trauma
• Allergy or sensitivity to Zyban, Wellbutrin or bupropion
• Undergoing abrupt withdrawal from alcohol, benzodiazepines or other sedatives
• Currently taking monoamine oxidase (MAO) inhibitors, or thioridazine
• Pregnant or breastfeeding or at risk of becoming pregnant
• Central nervous system (CNS) tumor
• Severe hepatic impairment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centre for Addiction and Mental Health

Overall Clinical Trial Officials and Contacts

Peter Selby, MBBS Principal Investigator Centre for Addiction and Mental Health  

Overall Contact: Laurie Zawertailo, PhD 416-535-8501 laurie_zawertailo@camh.net

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01015170

Study ID Number: 005/2008

ClinicalTrials.gov Identifier: NCT01015170

Health Authority: Canada: Health Canada