STOP Study: Effectiveness of Zyban in a Clinical Population

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
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: April 30, 2014
Last verified: April 2014
  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 2015
Estimated Primary Completion Date: March 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

  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
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 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 and Long Term Care
Investigators
Principal Investigator: Peter Selby, MD, MHSc Centre for Addiction and Mental Health
  More Information

Additional Information:
Publications:

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: April 30, 2014
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
Behavior, Addictive
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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 August 28, 2014