Completed

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

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What is being tested

Nicotine nasal spray

+ Placebo

+ Nicotine nasal spray

Drug
Who is being recruted

Mental Disorders+1

+ Attention Deficit and Disruptive Behavior Disorders

+ Neurodevelopmental Disorders

From 18 to 25 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorScott Kollins, PhD
Last updated: November 30, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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 more quickly, and have a harder time quitting. The specific factors that confer risk for smoking-related outcomes among those with ADHD have not been thoroughly evaluated, though a range of possibilities exist. 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. Target completion population of the study is 150 (75 ADHD, 75 CTRL), although the population potentially screened will be 200. The investigators will systematically assess the effects of two doses of intranasally administered nicotine versus placebo. In addition, nicotine self-administration will be evaluated under conditions that are likely to be more cognitively challenging among individuals with ADHD. If the subject passes screen and their status as never smoking up to 1 cigarette in their lifetime, they will be scheduled for a the first of five experimental sessions: 3 fixed dose sessions, followed by 2 choice sessions. Each of the 3 fixed dose sessions will be identical except for the dose of nicotine evaluated. During choice sessions, the nicotine reinforcement procedures will be implemented. Finally to assess the moderating effects of genotype on the reinforcing effects of nicotine in non-smokers analyses will focus primarily with hierarchical regression models that covary gender and population substructure to assess effects of genotype on nicotine sensitivity outcomes. Further epigenetics analysis will be conducted, related to the initial nicotine exposure at the Fixed Dose Sessions.

NCT01819259
Principal SponsorScott Kollins, PhD
Last updated: November 30, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

136 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 25 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersAttention Deficit Disorder with Hyperactivity

Criteria

Inclusion Criteria: 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 Criteria: 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
All participants will be non-smokers defined as never having smoked an entire cigarette and no tobacco use in the past 3 years. The group will then be split into those diagnosed with ADHD/ADD and controls for comparison.

Group II

Active Comparator
All participants will be non-smokers defined as never having smoked an entire cigarette and no tobacco use in the past 3 years. The group will then be split into those diagnosed with ADHD/ADD and controls for comparison.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Duke Child and Family Study Center

Durham, United StatesOpen Duke Child and Family Study Center in Google Maps
CompletedOne Study Center