NCT01015170|CompletedPhase 4Results
STOP Study: Effectiveness of Zyban in a Clinical Population
The STOP Study: Real World Effectiveness of Zyban Treatment in a Clinical Population
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Sponsor study identifier
interventional
454
1 country
24
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 17, 2009
Actual (reported)November 18, 2009
Actual (reported)October 2015
Actual (reported)October 2015
Actual (reported)March 27, 2017
Actual (reported)7-day Point Prevalence of Smoking Abstinence
Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked at week 8
End of Treatment (8 weeks after Zyban start date)
Serious Quit Attempt (at Least 24 Hours of Abstinence)
End of Treatment (8 weeks after Zyban start date)
7-day Point Prevalence of Smoking Abstinence
6 months after Zyban start date
Up to 8 week of bupropion SR (150mg BID) + counseling.
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, L9M0A9, Canada
Georgian Bay Family Health Team
Collingwood, Ontario, Canada
North Renfrew Family Health Team
Deep River, Ontario, Canada
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. doi: 10.1016/j.addbeh.2004.04.007.
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. doi: 10.1001/jama.288.4.468.
Peter Selby, MD, MHSc
Centre for Addiction and Mental Health
454 participants (actual enrollment reported by the registry).
First Submitted
November 17, 2009
First Posted
November 18, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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
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. doi: 10.1001/archpsyc.59.12.1162.
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. doi: 10.1016/j.pscychresns.2003.12.006.
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. doi: 10.1016/j.amepre.2004.09.007.
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. doi: 10.1016/s0149-2918(02)85130-x.
Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.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. doi: 10.1056/NEJM199710233371703.
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. doi: 10.1056/NEJM199903043400903.
Leshner AI. Addiction is a brain disease, and it matters. Science. 1997 Oct 3;278(5335):45-7. doi: 10.1126/science.278.5335.45.
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. doi: 10.1016/s0376-8716(02)00067-4.
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. doi: 10.1007/s002130050022.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
March 27, 2017
Results First Posted
March 27, 2017
Record last verified: 2017-02
No plan to share data
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