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STOP Study: Effectiveness of Zyban in a Clinical Population

This study has been completed.
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health Identifier:
First received: November 17, 2009
Last updated: February 7, 2017
Last verified: February 2017

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.

Condition Intervention Phase
Cigarette Smoking
Nicotine Addiction
Smoking Cessation
Drug: bupropion HCl
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The STOP Study: Real World Effectiveness of Zyban Treatment in a Clinical Population

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 Smoking Abstinence [ Time Frame: End of Treatment (8 weeks after Zyban start date) ]
    Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked at week 8

Secondary Outcome Measures:
  • Serious Quit Attempt (at Least 24 Hours of Abstinence) [ Time Frame: End of Treatment (8 weeks after Zyban start date) ]
    Number of participants who report a serious quit attempt at End of treatment

  • 7-day Point Prevalence of Smoking Abstinence [ Time Frame: 6 months after Zyban start date ]
    Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked 6 months after Zyban start date

Enrollment: 454
Study Start Date: October 2009
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupropion HCl
Up to 8 week of bupropion SR (150mg BID) + counseling.
Drug: bupropion HCl
150mg BID for up to 8 weeks + counseling
Other Name: Zyban

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01015170

Canada, Ontario
The Youth Centre
Ajax, Ontario, Canada
Cottage Country Family Health Team
Bracebridge, Ontario, Canada
Bramalea Community Health Centre
Brampton, Ontario, Canada
Aberdeen Downtown Nurse Practitioner Clinic
Brantford, Ontario, Canada
Beausoleil Family Health Centre
Christian Island, Ontario, Canada, L9M0A9
Georgian Bay Family Health Team
Collingwood, Ontario, Canada
North Renfrew Family Health Team
Deep River, Ontario, Canada
Elliot Lake Family Health Team
Elliot Lake, Ontario, Canada
Englehart & District Family Health Team
Englehart, Ontario, Canada
Stonegate Community Health Centre
Etobicoke, Ontario, Canada
Haliburton Highlands Family Health Team
Haliburton, Ontario, Canada
Algonquin Family Health Team
Huntsville, Ontario, Canada
Mary Beglund Community Health Centre
Ignace, Ontario, Canada
NorWest Community Health Centre
Longlac, Ontario, Canada
Summerville Family Health Team
Mississauga, Ontario, Canada
Mount Forest Family Health Team
Mount Forest, Ontario, Canada
Dufferin Area Family Health Team
Orangeville, Ontario, Canada
Somerset West Community Health Centre
Ottawa, Ontario, Canada
PrimaCare Community Family Health Team
Paris, Ontario, Canada
West Durham Family Health Team
Pickering, Ontario, Canada
Prince Edward Family Health Team
Picton, Ontario, Canada
Stratford Family Health Team
Stratford, Ontario, Canada
NorWest Community Health Centre
Thunder Bay, Ontario, Canada
Sandwich Community Health Centre
Windsor, Ontario, Canada
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Ministry of Health and Long Term Care
Principal Investigator: Peter Selby, MD, MHSc Centre for Addiction and Mental Health
  More Information

Additional Information:

Responsible Party: Dr. Peter Selby, Clinician Scientist, Addictions Program, Centre for Addiction and Mental Health Identifier: NCT01015170     History of Changes
Other Study ID Numbers: 005/2008
Study First Received: November 17, 2009
Results First Received: June 29, 2016
Last Updated: February 7, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan to share data

Keywords provided by Centre for Addiction and Mental Health:
smoking cessation
nicotine addiction
bupropion hydrochloride

Additional relevant MeSH terms:
Behavior, Addictive
Tobacco Use Disorder
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017