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:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT00593112
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects, 12-17 years of age.
2. ADHD subjects must meet study criteria for the "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA Protocol"; #2003-P-001313.
3. Control subjects must not meet full DSM-IV criteria for Attention Deficit Hyperactivity Disorder, or any other current major psychiatric disorder.
4. Each subject and his/her authorized legal representative must understand the nature of this proposed study, and must sign informed consent and informed assent documents.
5. Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with study procedures.
Exclusion Criteria:
1. Clinically significant chronic medical condition including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
2. Organic brain disorders or mental retardation (I.Q. \<75).
3. Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).
4. Pregnancy; women of child bearing potential must be using a medically approved method of birth control. Women of child bearing potential will receive a urinary pregnancy test prior to each MR scanning session.
5. Severe phobia of being in small, enclosed spaces.
6. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild will not be eligible to participate in the treatment arm of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT00593112
Study Brief:
Protocol Section:
NCT00593112