The MATCH (Medication Aids for Tobacco Cessation and Health) Study

Nicotine Dependence Clinical Trial

— MATCH  

Official title:

Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146911
• Other study ID #: 200/2012
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: January 31, 2017
• Start date: May 1, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2017
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 968
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Bupropion

• Varenicline

Behavioral:
• Weekly Motivational Emails
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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health, Nicotine Dependence Clinic	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Global Research Awards for Nicotine Dependence (GRAND)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genetic Polymorphisms	Polymorphisms in genes involved in treatment medication and nicotine's metabolism and receptors, as well as genetic variations involved in dopamine neurotransmitter pathway are investigated. DNA analysis is performed using mailed-in saliva samples.	About 5 weeks following participants' enrollment
Other	Personality Traits	The ten aspects of personality traits (2 aspects for each big five domains of personality), as described by BFAS (Big Five Aspect Scales), are measured.	At baseline
Primary	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	Pre-post Decisional Balance Scores	Related to physician practice changes after being approached by their patients about smoking cessation medications and being informed about the study.	upon first patient enrolled and 1 month following last patient enrolled
Secondary	Continuous Abstinence	A measure of long-term smoking cessation and time to relapse.	12, 26 and 52 weeks after start of treatment

External Links

•   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