Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts

NCT01023659 | Completed Phase 4 Results

• 1 other identifier: 068/2009
• Study Type: interventional
• Target: 893
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use Disorder; Smoking; Smoking Cessation

Keywords

Smoking cessation; Bupropion; Varenicline; Population-level; Mass distribution; Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Bupropion + motivational emails

ACTIVE COMPARATOR

participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.

Drug: bupropion; Behavioral: motivational emails

Varenicline + motivational emails

ACTIVE COMPARATOR

participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.

Drug: varenicline; Behavioral: motivational emails

Motivational emails

ACTIVE COMPARATOR

participants receive weekly motivational emails for 12 weeks.

Behavioral: motivational emails

Interventions

bupropion DRUG

bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks

Also known as: Zyban

Bupropion + motivational emails

varenicline DRUG

varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks

Also known as: Champix

Varenicline + motivational emails

motivational emails BEHAVIORAL

brief motivational emails, sent weekly for 12 weeks

Bupropion + motivational emails; Motivational emails; Varenicline + motivational emails

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1P7, Canada

Location

Related Publications (1)

• 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.

  PMID: 26429100 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Smoking Cessation

Interventions

Bupropion; Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Peter Selby
• Organization: Centre for Addiction and Mental Heatlh

peter.selby@camh.ca

416-535-8501

Study Officials

• Peter Selby, MD, MHSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Addictions Program

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 24, 2018
• Results First Posted: March 15, 2013

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)