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:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT01819259
Eligibility Criteria:
Inclusion Criteria:
1. 18-25 years of age.
2. male or female; if female of childbearing potential, must be using an acceptable form of contraception.
3. ADHD Diagnosis:
1. for ADHD Groups: confirmed diagnosis, any subtype as determined by the clinician administered CAADID and clinical interview.
2. for Control Groups: NO diagnosis of ADHD as determined by clinician administered CAADID and clinical interview.
4. ADHD Symptom Ratings:
1. for ADHD Groups: T-Score \> 65 on one of the DSM-IV relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on both the Self-Report and Observer versions of the CAARS.
2. for Control Groups: T-Score \< 60 on all of the DSM-IV relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on both the Self-Report and Observer versions of the CAARS.
5. never smoked an entire cigarette; no tobacco exposure in past 3 years.
6. expired air CO level \< 3 ppm; plasma nicotine levels \< 5 ng/mL.
7. cognitive functioning \> 80 as assessed by the Kaufman Brief Intelligence test, Second Edition(KBIT-II).
Exclusion Criteria:
1. history of chronic/significant medical condition.
2. current or past 12 month use of prescription medications for ADHD group.
3. meets criteria for any other Axis I Disorder (determined by the Structured Diagnostic Interview for DSM; SCID) other than nicotine dependence that is significantly impairing and would contraindicate participation in the present study.
4. meets criteria for any Axis II Disorder.
5. current substance abuse or dependence or history within the last 12 months; expired breath alcohol level \> 0.0; Positive urine drug screen for any of the following: cannabis, amphetamines, opioids, benzodiazepines, barbiturates, cocaine.
6. inability to understand written and/or spoken English language.
7. reported uncertainty about being able to remain a nonsmoker in the coming year.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT01819259
Study Brief:
Protocol Section:
NCT01819259