NCT02146911

Brief Summary

Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline are available to help smokers quit but there are not widely used. The primary objective of this study is to evaluate the real-world long-term effectiveness of of bupropion and varenicline treatment in a community sample of smokers interested in quitting. The investigators hypothesize that varenicline treatment will result in higher quit rates at end of treatment and at one year after treatment compared to bupropion. Smoking status will be biochemically confirmed at various time points using salivary cotinine measures. Furthermore, since 50% of the variation in quit success is genetically determined, and the effectiveness of different cessation medication may differ considerably in sub-groups of smokers carrying certain genetic variants, the investigators will collect saliva samples from consenting participants to evaluate the moderating effect of genetics on treatment response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
968

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

May 20, 2014

Last Update Submit

January 31, 2017

Conditions

Keywords

Smoking Cessation MedicationSmoking TreatmentTobacco TreatmentQuitting SmokingBupropionVareniclineEfficacyPharmacogenetics of Smoking TreatmentGenetics analysisSmoking PersonalityDependenceAddictionCigarettesPrimary Care PhysiciansBiochemical Confirmation

Outcome Measures

Primary Outcomes (1)

  • Change in smoking status over time

    Related to effectiveness of smoking cessation intervention, The 7-day point prevalence abstinent rate is defined as not having smoked, even a puff, over the previous seven days.

    At 12, 26, and 52 weeks following start of treatment

Secondary Outcomes (2)

  • Pre-post Decisional Balance Scores

    upon first patient enrolled and 1 month following last patient enrolled

  • Continuous Abstinence

    12, 26 and 52 weeks after start of treatment

Other Outcomes (2)

  • Genetic Polymorphisms

    About 5 weeks following participants' enrollment

  • Personality Traits

    At baseline

Study Arms (2)

Bupropion

EXPERIMENTAL

Bupropion hydrochloride SR, Sandoz Canada, Boucherville, Quebec. Dispense for 12 weeks. One tablet (150mg) once daily for first three days, then twice daily for the remainder of 12 weeks.

Drug: BupropionBehavioral: Weekly Motivational Emails

Varenicline

EXPERIMENTAL

Varenicline tartrate (Champix®), Pfizer Canada Inc., Kirkland, Quebec. Dispense for 12 weeks. One tablet (0.5mg) once daily for first three days, then one tablet (0.5 mg) twice daily for next four days, then 1 mg (one 1mg tablet or two 0.5mg tablets) twice daily for the remainder of 12 weeks.

Drug: VareniclineBehavioral: Weekly Motivational Emails

Interventions

Bupropion
Varenicline

The e-mails will include tips on several things other than the medications that participants can do to help them quit smoking. The contents of the emails will vary from week to week. The e-mails will provide tips on ways to create an atmosphere that promotes quitting and staying abstinence. They will also include recommendations on how to address issues with withdrawal symptoms and cravings. In addition, they will provide positive motivational messages by stating facts on benefits of quitting smoking.

BupropionVarenicline

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 19 years of age
  • Smoking at least 10 cigarettes per day
  • Smoked daily for at least the past year
  • Have an intention of quit smoking in the next 30 days.

You may not qualify if:

  • History of psychotic disorder or eating disorder
  • Brain injury
  • Seizure disorder
  • Pregnancy, lactation, or at risk of becoming pregnant
  • Allergy or sensitivity to bupropion or varenicline
  • Taking monoamine oxidase inhibitors (anti-depressants), thioridazine or Wellbutrin or other medication containing bupropion hydrochloride.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health, Nicotine Dependence Clinic

Toronto, Ontario, M5T 1P7, Canada

Location

Related Publications (2)

  • Zhang H, Mansoursadeghi-Gilan T, Hussain S, Veldhuizen S, Le Foll B, Selby P, Zawertailo L. Evaluating the effectiveness of bupropion and varenicline for smoking cessation using an internet-based delivery system: A pragmatic randomized controlled trial (MATCH study). Drug Alcohol Depend. 2022 Mar 1;232:109312. doi: 10.1016/j.drugalcdep.2022.109312. Epub 2022 Feb 9.

  • Zawertailo L, Mansoursadeghi-Gilan T, Zhang H, Hussain S, Le Foll B, Selby P. Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 18;7(10):e10826. doi: 10.2196/10826.

Related Links

MeSH Terms

Conditions

Tobacco Use DisorderSmoking CessationBehavior, Addictive

Interventions

BupropionVarenicline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehaviorCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Laurie Zawertailo, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Independent Scientist

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 26, 2014

Study Start

May 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

February 2, 2017

Record last verified: 2017-01

Locations