Status:
COMPLETED
Varenicline and Bupropion for Smoking Cessation
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
University of Minnesota
Conditions:
Smoking
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ ...
Detailed Description
Cigarette smoking is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States and accounts for 30% of U.S. cancer deaths. Varenicline and b...
Eligibility Criteria
Inclusion
- Subject is at least 18 years of age;
- Subject has provide written informed consent;
- Subject is smoking greater than or equal to 10 cigarettes per day for at least 6 months;
- 3\) Subject is able to complete all study visits 4) Subject is in good health as determined by the investigator 5) Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments 6) Subject is motivated to stop smoking.
Exclusion
- Female and were pregnant, lactating or likely to become pregnant during the trial and not able nor willing to use contraception or had:
- an unstable medical condition;
- another household member participating in the study;
- bupropion or varenicline allergy;
- current use (previous 30 days) of a tobacco dependence treatment and unable or unwilling to discontinue use;
- an unstable medical condition or unstable angina, myocardial infarction, or coronary angioplasty (past 3 months) or an untreated cardiac dysrhythmia;
- a history of renal failure or were on renal dialysis;
- a history of seizures;
- as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts or lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
- a history of closed head trauma associated with \> 30 minutes of loss of consciousness, amnesia, skull fracture, subdural hematoma, or brain contusion;
- a history or psychosis, bipolar disorder, bulimia or anorexia nervosa;
- current moderate or severe depression as assessed by a score of ≥ 20 on the Beck Depression Inventory, Second Edition (BDI-II) 10;
- active substance abuse other than nicotine;
- current (past 14 days) use of an antipsychotic, monoamine oxidase inhibitors, or drugs known to interact with bupropion SR;
- a recent dose change of their antidepressant (within last 3 months);
- untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100;
- current treatment with another investigational drug for tobacco dependence (previous 30 days); or
- current use of bupropion or varenicline (previous 30 days).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT00935818
Start Date
September 1 2009
End Date
April 1 2013
Last Update
May 9 2014
Active Locations (3)
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1
University Of Minnesota
Minneapolis, Minnesota, United States, 55414
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Franciscan Skemp Hospital
La Crosse, Wisconsin, United States, 54601