Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 6months;
- Subject is able to complete all study visits 4) Subject is in good health as determinedby the investigator 5) Subject has the ability to participate fully in all aspects of thestudy and keep scheduled appointments 6) Subject is motivated to stop smoking.
Exclusion
Exclusion Criteria: Female and were pregnant, lactating or likely to become pregnant during the trial and notable 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 orunwilling to discontinue use;
an unstable medical condition or unstable angina, myocardial infarction, or coronaryangioplasty (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), currentnon-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 resultof 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 BeckDepression Inventory, Second Edition (BDI-II) 10;
active substance abuse other than nicotine;
current (past 14 days) use of an antipsychotic, monoamine oxidase inhibitors, or drugsknown 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).
Study Design
Study Description
Connect with a study center
University Of Minnesota
Minneapolis, Minnesota 55414
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Franciscan Skemp Hospital
LaCrosse, Wisconsin 54601
United StatesSite Not Available

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