Nicotine, Non-Smokers With and Without ADHD, and Genetics Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Non-smoker, ADHD

In brief

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 laboratory-based model of intranasal nicotine administration. Study Hypotheses: 1. that nicotine will produce greater positive and fewer negative/aversive subjective effects in individuals with ADHD. The study team also hypothesizes that nicotine will improve performance to a greater degree in those with ADHD. 2. that individuals in the ADHD group will exhibit an increase in choices for nicotine vs. placebo in both conditions (i.e., main effect) and that this effect will be more pronounced in the High Demand vs. Low Demand conditions (i.e. Group x Condition interaction). Also that greater performance enhancing effects of nicotine will be associated with greater nicotine choice during the high demand cognitive condition. 3. that the main effects of ADHD status on nicotine reinforcement will be heightened in the presence of certain genotypes. Also that the main effects of ADHD status on nicotine reinforcement will be heightened in the presence of certain genotypes. Finally that exposure to nicotine will alter epigenetic patterns in DNA

Key facts

Study ID

NCT01819259

Run by

Scott Kollins, PhD

People needed

136

Starts

2013-01-01

Expected to finish

2018-06-30

Last updated by the study team

2018-11-30

Who can join

Age: 18 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Duke Child and Family Study Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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