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STOP Study: Effectiveness of Zyban in a Clinical Population

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 18, 2009
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health

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: None (Open Label)
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 Dr. Peter Selby, 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


Information from the National Library of Medicine

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, Learn About Clinical Studies.

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Alberg AJ, Stashefsky Margalit R, Burke A, Rasch KA, Stewart N, Kline JA, Ernst PA, Avey A, Hoffman SC. The influence of offering free transdermal nicotine patches on quit rates in a local health department's smoking cessation program. Addict Behav. 2004 Dec;29(9):1763-78.
Ahluwalia JS, Harris KJ, Catley D, Okuyemi KS, Mayo MS. Sustained-release bupropion for smoking cessation in African Americans: a randomized controlled trial. JAMA. 2002 Jul 24-31;288(4):468-74.
Brody AL, Mandelkern MA, London ED, Childress AR, Lee GS, Bota RG, Ho ML, Saxena S, Baxter LR Jr, Madsen D, Jarvik ME. Brain metabolic changes during cigarette craving. Arch Gen Psychiatry. 2002 Dec;59(12):1162-72.
Brody AL, Mandelkern MA, Lee G, Smith E, Sadeghi M, Saxena S, Jarvik ME, London ED. Attenuation of cue-induced cigarette craving and anterior cingulate cortex activation in bupropion-treated smokers: a preliminary study. Psychiatry Res. 2004 Apr 30;130(3):269-81. Erratum in: Psychiatry Res. 2004 Dec 15;132(2):183-4.
Cokkinides VE, Ward E, Jemal A, Thun MJ. Under-use of smoking-cessation treatments: results from the National Health Interview Survey, 2000. Am J Prev Med. 2005 Jan;28(1):119-22.
Durcan MJ, Deener G, White J, Johnston JA, Gonzales D, Niaura R, Rigotti N, Sachs DP. The effect of bupropion sustained-release on cigarette craving after smoking cessation. Clin Ther. 2002 Apr;24(4):540-51.
Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. Review. Update in: Cochrane Database Syst Rev. 2002;(1):CD000031.
Hurt RD, Sachs DP, Glover ED, Offord KP, Johnston JA, Dale LC, Khayrallah MA, Schroeder DR, Glover PN, Sullivan CR, Croghan IT, Sullivan PM. A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med. 1997 Oct 23;337(17):1195-202.
Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA, Hughes AR, Smith SS, Muramoto ML, Daughton DM, Doan K, Fiore MC, Baker TB. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med. 1999 Mar 4;340(9):685-91.
Leshner AI. Addiction is a brain disease, and it matters. Science. 1997 Oct 3;278(5335):45-7.
Lerman C, Roth D, Kaufmann V, Audrain J, Hawk L, Liu A, Niaura R, Epstein L. Mediating mechanisms for the impact of bupropion in smoking cessation treatment. Drug Alcohol Depend. 2002 Jul 1;67(2):219-23.
Shiffman S, Johnston JA, Khayrallah M, Elash CA, Gwaltney CJ, Paty JA, Gnys M, Evoniuk G, DeVeaugh-Geiss J. The effect of bupropion on nicotine craving and withdrawal. Psychopharmacology (Berl). 2000 Jan;148(1):33-40.

Responsible Party: Dr. Peter Selby, Clinician Scientist, Addictions Program, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01015170     History of Changes
Other Study ID Numbers: 005/2008
First Submitted: November 17, 2009
First Posted: November 18, 2009
Results First Submitted: June 29, 2016
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data

Keywords provided by Dr. Peter Selby, 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

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