Phase 4
Completed N=454
STOP Study: Effectiveness of Zyban in a Clinical Population
Cigarette Smoking · Nicotine Addiction · Smoking Cessation
Source: ClinicalTrials.gov NCT01015170 ↗
Enrolled (actual)
454
Serious AEs
1.8%
Results posted
Mar 2017
Primary outcomePrimary: 7-day Point Prevalence of Smoking Abstinence — 109; 106 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence of Smoking Abstinence |
320; 128 | — |
| SECONDARY Serious Quit Attempt (at Least 24 Hours of Abstinence) |
— | — |
| SECONDARY 7-day Point Prevalence of Smoking Abstinence |
320; 128 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01015170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.