Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)

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.