| Criteria: |
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Inclusion Criteria:
- Male and female outpatients from 18-60 years of age;
- A cigarette smoking history of at least 3 months, and currently smoking;
- An interest in quitting smoking and a willingness to comply with all study procedures
and medication instructions;
- A current DSM-IV-TR diagnosis of ADHD confirmed by clinical psychiatric evaluation
and/or ADHD module of structured diagnostic interview, completed by study clinician.
- For females of child-bearing potential: pregnancy test at screening visit is negative
and the subject does not plan to become pregnant during the study.
Exclusion Criteria:
- Pregnancy or breast-feeding;
- Clinically significant and/or unstable medical condition including renal, hepatic, or
neurological, based upon a medical history and vital signs;
- Ongoing treatment with medications which may be affected (altered blood levels) if
subjects stop smoking in the study, including insulin, theophylline, and blood
thinners, as determined by clinician;
- Clinically significant cardiovascular history, including myocardial infarction,
untreated hypertension, atrial fibrillation, or arrhythmia;
- Current untreated psychiatric comorbidity which the investigator judges to be of
greater than mild severity, including Major Depressive Disorder;
- Current psychiatric comorbidity, including suicidality, homicidality, psychosis,
determined by the clinician to be clinically significant and/or unstable
- Lifetime history of DSM-IV Bipolar I disorder, Schizophrenia, or suicide attempt as
determined through clinical evaluation or diagnostic interview;
- Currently (within 3 months) meets DSM-IV criteria for abuse or dependence for any
psychoactive substance other than nicotine;
- Current treatment with mood stabilizers, anti-psychotics, nicotine replacement
therapies, or varenicline;
- Mental retardation (IQ < 75);
- History of intolerance or allergy to varenicline.
- Clinically significant abnormal screening values including:
- Consistent readings of hypertension (>140/90) during screening period (including
screening and baseline visits), defined as two or more readings (each being the
average of three measurements) at a single visit with systolic blood pressure,
SBP > 140 and/or diastolic blood pressure, DBP, > 90, and confirmed by manual
reading.
Subjects with isolated incidences (of triplicate average BP) of SBP > 140 and/or DBP > 90
at baseline/week 0 visit, confirmed by manual reading, which are determined to be
clinically significant. |