Status:
COMPLETED
Nicotine, Non-Smokers With and Without ADHD, and Genetics Study
Lead Sponsor:
Scott Kollins, PhD
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Non-smoker
ADHD
Eligibility:
All Genders
18-25 years
Phase:
PHASE1
Brief Summary
The overall goal of the proposed research is to evaluate the behavioral and genetic mechanisms of smoking risk in non-smoking young adults (aged 18-25 years of age) with and without ADHD using a novel...
Detailed Description
Individuals with Attention Deficit Hyperactivity Disorder (ADHD) are more likely to smoke cigarettes than the general population, start smoking at a younger age, progress to regular use and dependence...
Eligibility Criteria
Inclusion
- 18-25 years of age.
- male or female; if female of childbearing potential, must be using an acceptable form of contraception.
- ADHD Diagnosis:
- for ADHD Groups: confirmed diagnosis, any subtype as determined by the clinician administered CAADID and clinical interview.
- for Control Groups: NO diagnosis of ADHD as determined by clinician administered CAADID and clinical interview.
- ADHD Symptom Ratings:
- 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.
- 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.
- never smoked an entire cigarette; no tobacco exposure in past 3 years.
- expired air CO level \< 3 ppm; plasma nicotine levels \< 5 ng/mL.
- cognitive functioning \> 80 as assessed by the Kaufman Brief Intelligence test, Second Edition(KBIT-II).
Exclusion
- history of chronic/significant medical condition.
- current or past 12 month use of prescription medications for ADHD group.
- 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.
- meets criteria for any Axis II Disorder.
- 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.
- inability to understand written and/or spoken English language.
- reported uncertainty about being able to remain a nonsmoker in the coming year.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT01819259
Start Date
January 1 2013
End Date
June 30 2018
Last Update
November 30 2018
Active Locations (1)
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1
Duke Child and Family Study Center
Durham, North Carolina, United States, 27705