Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00907218
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00907218
Study Brief:
Protocol Section:
NCT00907218