Chantix & Bupropion for Smoking Cessation
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking; Tobacco Use Disorder
Intervention: Chantix (Varenicline) & Bupropion (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Jon O Ebbert, MD, Principal Investigator, Affiliation: Mayo Clinic
Summary
The overarching goal of this line of research is to increase smoking abstinence rates using a
combination of existing pharmacotherapies. The aim of the current study is to assess the
safety and compliance as well as obtain preliminary estimates of efficacy and effect on
craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We
will compare the efficacy estimates in this study with historical smoking abstinence rates
with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an
open-label, phase II clinical trial.
Clinical Details
Official title: Combination Pharmacotherapy With Chantix & Bupropion for Smoking Cessation (ChanBan)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To obtain preliminary evidence of efficacy of 12 weeks of combination therapy with bupropion SR and varenicline for increasing the point prevalence smoking abstinence rates at 12 weeks among cigarette smokers.
Secondary outcome: 1. To assess the types and frequencies of side effects with 12 weeks of combination therapy with bupropion SR and varenicline for the treatment of tobacco dependence among cigarette smokers.
Detailed description:
Subjects will be eligible to participate if they: 1) are at least 18 years of age; 2) have
smoked 10 or more cigarettes per day for at least 6 months; and 3) are motivated to stop
smoking.
Subjects will be excluded if they have: 1) an unstable medical condition; 2) unstable angina,
myocardial infarction, or coronary angioplasty within the past 3 months or an untreated
cardiac dysrhythmia; 3) personal history of seizures; 4) closed head trauma with any loss of
consciousness or amnesia in the last 5 years; 5) ever history of closed head trauma with > 30
minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural
hematoma/brain contusion; 6) a history or psychosis, bipolar disorder, bulimia or anorexia
nervosa); 7) have current depression as assessed by Center for Epidemiologic Studies
Depression (CES-D); 8) have active substance abuse other than nicotine; 9) have used an
investigational drug within the last 30 days; 10) are currently using a behavioral or
pharmacologic tobacco treatment and unwilling or unable to discontinue use; 11) use of
bupropion or varenicline in the previous 3 months; 12) current (past 14 days) use of
antipsychotic or antidepressant; 13) an allergy to bupropion or varenicline; 14) untreated
hypertension or baseline systolic blood pressure > 180 or diastolic > 100; 15) have another
member of their household already participating in this study.
The primary aims and hypotheses of this study are:
1. To obtain preliminary evidence of efficacy of 12 weeks of combination therapy with
bupropion SR and varenicline for increasing the point prevalence smoking abstinence
rates at 12 weeks among cigarette smokers.
Hypothesis: The combination of bupropion SR plus varenicline for 12 weeks will increase
the point prevalence smoking abstinence rates at 12 weeks among cigarettes smokers.
2. To obtain preliminary evidence of efficacy of combination therapy with bupropion SR and
varenicline for decreasing craving and nicotine withdrawal symptoms among cigarette
smokers trying to achieve smoking abstinence.
Hypothesis: 12 weeks of combination therapy with bupropion SR and varenicline will
significantly decrease craving and nicotine withdrawal among cigarette smokers trying to
achieve smoking abstinence.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- at least 18 years of age
- have smoked 10 or more cigarettes per day for at least 6 months
- are motivated to stop smoking.
Exclusion Criteria:
- an unstable medical condition
- unstable angina, myocardial infarction, or coronary angioplasty within the past 3
months or an untreated cardiac dysrhythmia
- personal history of seizures
- closed head trauma with any loss of consciousness or amnesia in the last 5 years
- ever history of closed head trauma with > 30 minutes of loss of consciousness or
amnesia or resulting in skull fracture or subdural hematoma/brain contusion
- a history or psychosis, bipolar disorder, bulimia or anorexia nervosa)
- have current depression as assessed by Center for Epidemiologic Studies Depression
(CES-D)
- have active substance abuse other than nicotine
- have used an investigational drug within the last 30 days
- are currently using a behavioral or pharmacologic tobacco treatment and unwilling or
unable to discontinue use
- use of bupropion or varenicline in the previous 3 months
- current (past 14 days) use of antipsychotic or antidepressant
- an allergy to bupropion or varenicline
- untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100
- have another member of their household already participating in this study.
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55902, United States
Additional Information
Mayo Clinic Nicotine Research Program Mayo Clinic Clinical Trials
Starting date: July 2007
Ending date: July 2008
Last updated: December 21, 2007
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