The MATCH (Medication Aids for Tobacco Cessation and Health) Study
Condition: Tobacco Use Disorder; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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.
    

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.
    

Intervention name(s): Bupropion; Varenicline; Weekly Motivational Emails
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 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.
Intervention MeSH terms: Bupropion; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation Medication; Smoking Treatment; Tobacco Treatment; Quitting Smoking; Bupropion; Varenicline; Efficacy; Pharmacogenetics of Smoking Treatment; Genetics analysis; Smoking Personality; Dependence; Addiction; Cigarettes; Primary Care Physicians; Biochemical Confirmation