STOP Study: Effectiveness of Zyban in a Clinical Population
This study is ongoing, but not recruiting participants.
Sponsor:
Centre for Addiction and Mental Health
Collaborator:
Ontario Ministry of Health Promotion and Sport
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01015170
First received: November 17, 2009
Last updated: February 13, 2013
Last verified: February 2013
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Purpose
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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 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), 6 months after end of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serious quit attempt (at least 24 hours of abstinence) [ Time Frame: End of Treatment (8 weeks after Zyban start date), 6 months after end of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 750 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015170
Locations
| 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 | |
| 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 Promotion and Sport
Investigators
| Principal Investigator: | Peter Selby, MD, MHSc | Centre for Addiction and Mental Health |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Peter Selby, Clinical Director, Addictions Program, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT01015170 History of Changes |
| Other Study ID Numbers: | 005/2008 |
| Study First Received: | November 17, 2009 |
| Last Updated: | February 13, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre for Addiction and Mental Health:
|
smoking cessation nicotine addiction Zyban bupropion hydrochloride |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Smoking Behavior, Addictive Substance-Related Disorders Mental Disorders Habits Compulsive Behavior Impulsive Behavior Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013