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| Name | Class |
|---|---|
| Ontario Ministry of Health and Long Term Care | OTHER_GOV |
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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.
Nicotine dependence, like other addictive disorders, can be characterized as a chronic, relapsing disease (Leshner, 1997). Although there is significant morbidity and mortality associated with this disorder, the majority of smokers are not treated adequately to the widely accepted goal of complete long-term abstinence from smoking. This may be due to the under-utilization of accepted pharmacotherapies for the treatment of tobacco dependence.
Bupropion (Zyban) Bupropion is the first line of non-nicotine-based pharmacotherapy for smoking cessation. Several large-scale clinical trials have shown bupropion to be an efficacious smoking cessation aid (Hurt et al., 1997; Jorenby et al., 1999; Ahluwalia et al., 2002). In one such study, a 44% abstinence rate was reported for seven weeks of treatment with bupropion at 300 mg/day, compared to 19% for placebo (Hurt et al, 1997). A recent meta-analysis has reported that bupropion monotherapy approximately doubles the rate of smoking cessation (OR 1.94) (Hughes et al, 2007).
Despite its efficacy, bupropion's mechanism of action is unclear. Attenuation of abstinence-associated increase in craving and withdrawal symptoms has been suggested as possible mechanisms of bupropion's effect on smoking behaviour in a few randomized clinical trials (Jorneby et al., 1999; Shiffman et al., 2000; Lerman et al., 2002; Durcan et al, 2002). However, these effects are not universally demonstrated (Hurt et al., 1997; Shiffman et al., 2000). Other possible bio-behavioral mechanisms have remained largely unexplored. Using positron emission tomography (PET) it has been shown that in contrast to untreated smokers, when bupropion-treated smokers were exposed to cigarette-related cues there was less metabolic activation in their anterior cingulate cortex, a region of the brain previously shown to be activated by cigarette cues (Brody et al., 2004;Brody et al., 2002).
STOP Study Background and Rationale
Treatment with pharmacotherapy such as nicotine replacement therapy (NRT) or Zyban is a safe and effective smoking cessation strategy that can double the chance of quitting successfully over the long-term (Cornuz, 2007). However, research has shown that most smokers who are interested in quitting do not use pharmacotherapy to aid in their quit attempt. Misconceptions about the harmful effects of nicotine are a strong barrier to the use of pharmacotherapy. The cost of pharmacotherapy may also be a significant contributor to the under-utilization of smoking cessation aids such as NRT and Zyban. Karnath (2001) suggested that the high cost of successful pharmacotherapy treatment for smoking cessation may be a barrier for some individuals. Moreover, Cokkinides et al (2005) reported that smokers with private insurance were more likely to use smoking cessation pharmacotherapies than smokers without insurance. The addition of free NRT to a group behavioural cessation program substantiated these claims by showing an increase in quit rates from 38% to 65% (Alberg et al, 2004). These studies suggest that economic barriers may prevent smokers from using pharmacotherapy in their attempts to quit smoking.
The study proposed herein will introduce free bupropion as another treatment option for smoking cessation for Ontario smokers. Community Health Centres and Aboriginal Health Access Centres are interdisciplinary health models that are able to help individuals who would otherwise be prevented from accessing health services due to social and geographic barriers. As they aim to eliminate these other barriers and consequently control for them, they are an ideal health model for determining whether eliminating the economic barriers of smoking cessation improves smoking cessation rates. Family Health Teams are more recent health models that provide integrated and interdisciplinary primary health care. Since they are able to treat large and diverse populations, they are an ideal health model for accessing Ontario smokers.
Objectives
1. To evaluate the effectiveness of 8-weeks of free bupropion in combination with brief counselling through family health teams, community health centres and aboriginal health access centres in Ontario for smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion HCl | Experimental | Up to 8 week of bupropion SR (150mg BID) + counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupropion HCl | Drug | 150mg BID for up to 8 weeks + counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Quit Attempt (at Least 24 Hours of Abstinence) | Number of participants who report a serious quit attempt at End of treatment | End of Treatment (8 weeks after Zyban start date) |
| 7-day Point Prevalence of Smoking Abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Selby, MD, MHSc | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Youth Centre | Ajax | Ontario | Canada | |||
| Cottage Country Family Health Team |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15530720 | Background | 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. | |
| 12132977 | Background |
| Label | URL |
|---|---|
| Click here for more information about the study: STOP Study: Effectiveness of Zyban in a Clinical Population | View source |
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No plan to share data
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupropion HCl | Up to 8 week of bupropion SR (150mg BID) + counseling. bupropion HCl: 150mg BID for up to 8 weeks + counseling |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked 6 months after Zyban start date
| 6 months after Zyban start date |
| 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 |
| 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 |
| 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. |
| 12470133 | Background | 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. |
| 15135160 | Background | 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. |
| 15626567 | Background | 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. |
| 12017399 | Background | 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. |
| 11034670 | Background | Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.CD000031. |
| 9337378 | Background | 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. |
| 10053177 | Background | 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. |
| 9311924 | Background | 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. |
| 12095672 | Background | 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. |
| 10663415 | Background | 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. |
| Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre. | View source |
| COMPLETED |
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| NOT COMPLETED |
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Ontario smokers who are interested in quitting smoking.
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| ID | Title | Description |
|---|---|---|
| BG000 | Buproprion & Behavioural Support | 8 weeks of buproprion-SR + brief counselling for smoking cessation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Education level attained | highest level of education attained | Number | participants |
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| Employment | Number | participants |
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| Income category | Number | participants |
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| Cigarettes per day (cpd) | # cigarettes smoked per day | Mean | Standard Deviation | # cigarettes smoked per day |
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| Age first smoked | Mean | Standard Deviation | years |
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| Age smoked daily | Mean | Standard Deviation | years |
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| Time to first morning cigarette | Number | participants |
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| # quit attempts in the past | Number | participants |
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| Importance of quitting smoking | scale of importance of quitting (1 to 10) 1 - least important 10- most important | Mean | Standard Deviation | units on a scale |
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| Confidence in quitting smoking | Confidence in quitting smoking 1- very little confidence 10- very confident | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| Ever had a psychiatric diagnosis | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Participants who completed survey 8 weeks after Zyban start date | Posted | Number | participants | End of Treatment (8 weeks after Zyban start date) |
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| Secondary | Serious Quit Attempt (at Least 24 Hours of Abstinence) | Number of participants who report a serious quit attempt at End of treatment | This secondary outcome was not collected at 8 week followup. | Posted | End of Treatment (8 weeks after Zyban start date) |
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| Secondary | 7-day Point Prevalence of Smoking Abstinence | Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked 6 months after Zyban start date | Number of participants who completed 6 month post treatment survey | Posted | Count of Participants | Participants | 6 months after Zyban start date |
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|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupropion HCl | Up to 8 week of bupropion SR (150mg BID) + counseling. bupropion HCl: 150mg BID for up to 8 weeks + counseling | 8 | 454 | 0 | 454 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| head injury | Injury, poisoning and procedural complications | Systematic Assessment | Participant fell and hospitalized for head injury |
| |
| wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | ER visit for wheezing |
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| Mental Health issues | Psychiatric disorders | Systematic Assessment | ER visit for mental health issues |
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| Chest pain | Cardiac disorders | Systematic Assessment | ER visit for Chest pain |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment | ER visit for Pancreatitis |
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| Loss of consciousess | Nervous system disorders | Systematic Assessment | Loss of consciousness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Selby; Dr. Laurie Zawertailo Principal Investigator | Centre for Addiction and Mental Health | 416-535-8501 | 77422 | laurie.zawertailo@camh.ca |
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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