Smoking Cessation Clinical Trial
Official title:
An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.
Verified date | January 2018 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bupropion and varenicline are indicated for smoking cessation. The objectives of this study are two-fold: (1) to explore the logistic feasibility of distributing bupropion and varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will enroll via the study website, visit their physician to receive a prescription for bupropion or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison group. All participants will receive weekly motivational emails for 12 weeks. Abstinence measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of eligible participants who were able to confirm an appointment with a physician to receive the prescription will be also measured.
Status | Completed |
Enrollment | 893 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - male or female, at least 18 years of age, resident of Ontario, smoke at least 10 cigarettes per day, had smoked daily for at least the past 3 months, had smoked at least 100 cigarettes in their lifetime and intended to quit smoking in the next 30 days. Exclusion Criteria: - history of brain injury or seizure(s); pregnancy, lactation or risk of becoming pregnant; allergy or sensitivity to bupropion or varenicline; current use of monoamine oxidase inhibitors (MAOIs), thioridazine, varenicline or buproprion; severe liver impairment; or history of anorexia and /or bulimina. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | Ontario Ministry of Health and Long Term Care |
Canada,
Selby P, Hussain S, Voci S, Zawertailo L. Empowering smokers with a web-assisted tobacco intervention to use prescription smoking cessation medications: a feasibility trial. Implement Sci. 2015 Oct 1;10:139. doi: 10.1186/s13012-015-0329-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 7-day Point Prevalence of Abstinence | 7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?" | 6-month | |
Primary | Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician | Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed | End of Treatment |
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