The MATCH (Medication Aids for Tobacco Cessation and Health) Study
Information source: Centre for Addiction and Mental Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tobacco Use Disorder; Nicotine Dependence
Intervention: Bupropion (Drug); Varenicline (Drug); Weekly Motivational Emails (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: Centre for Addiction and Mental Health Official(s) and/or principal investigator(s): Laurie Zawertailo, PhD, Principal Investigator, Affiliation: Centre for Addiction and Mental Health
Overall contact: Laurie Zawertailo, Phone: 416-535-8501, Ext: 77422, Email: laurie.zawertailo@camh.ca
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.
Clinical Details
Official title: Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in smoking status over time
Secondary outcome: Pre-post Decisional Balance ScoresContinuous Abstinence
Detailed description:
Only a fraction of smokers receive information about effective prescription-only smoking
pharmacotherapies, bupropion and varenicline. Moreover, studies have demonstrated variable
smoking cessation treatment outcomes correlate with individuals' genotypes and phenotypes.
Mass distribution approaches, bypassing clinics and physicians, have been successful for
nicotine replacement therapy. The primary objective of this study is to evaluate the
real-world long-term effectiveness of mailed bupropion and varenicline treatment in a sample
of interested smokers, utilizing web-based recruitment and follow-up. As part of the
Genetics Sub-study, the pharmacogenetics of these smoking cessation medications is
investigated. This is an open label study, wherein eligible participants will be randomized
to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in conjunction with
weekly motivational emails. Participants will spend approximately 20-30 minutes enrolling in
the study through the study's website. During this time, they will read the consent form,
answer the eligibility questions and complete the baseline questionnaire. Eligible
participants are then asked if they are interested to participate in the Genetics Sub-study.
Those who provide separate consent for the genetics component will complete additional
questionnaires online (Between Facets and Domains Personality Test) and will be mailed a kit
to provide a saliva sample. After successful completion of baseline questionnaire through
the study website, eligible participants will be emailed a Letter to Doctor and a Standard
Script to take to their doctor. Then, they will attend an appointment with their physician
to discuss with their doctor whether the medication they have been assigned to is
appropriate for them to use as smoking cessation aid. It is possible that the participant
and his/her doctor will decide not to pursue smoking cessation using the assigned
medication. These participants will still receive the weekly motivational emails and will be
followed up at all time points, but they will not be included in the main data analysis. If
the doctor believes that it is appropriate for the participants to take the assign
medication, he/she will need to sign the Standard Script and fax it to the study contract
pharmacy. Once the fax is received by the pharmacy, they will call the participants for a
brief counseling. Then, they will fill the prescription and mail the medication to you free
of charge. All participants will set a quit date of their choosing, but will start the
medication 7 days prior to their target quit date. Data related to the outcome measures and
adverse events will be collected at 4, 8 and 12, 26 and 52 weeks after the start of
treatment in order to assess and compare both point prevalent and continuous abstinence
effects of the two treatment interventions. Smoking status will be biochemically confirmed
at baseline and at 26th and 52nd weeks following start of treatment using salivary cotinine
measures. Medication compliance is assessed by self-report measures as part of the follow-up
questionnaire. Compliance is also biochemically confirmed at 4 weeks following start of
treatment.
Eligibility
Minimum age: 19 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Laurie Zawertailo, Phone: 416-535-8501, Ext: 77422, Email: laurie.zawertailo@camh.ca
Centre for Addiction and Mental Health, Nicotine Dependence Clinic, Toronto, Ontario M5T 1P7, Canada; Recruiting Laurie Zawertailo, Phone: 416-535-8501, Ext: 77422, Email: laurie.zawertailo@camh.ca Laurie Zawertailo, PhD, Principal Investigator
Additional Information
Link Text: Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre
Starting date: May 2014
Last updated: August 19, 2015
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