Neuroimaging of Smokers With and Without Attention Deficit Hyperactivity Disorder (ADHD)

NCT01123668 | Completed

• 2 other identifiers: Pro000090851R01DA024838-01A1
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how nicotine, withdrawal from nicotine, and methylphenidate (a drug used for the treatment of ADHD) affect the brain of smokers with and without ADHD while doing tasks in an functional Magnetic Resonance Imaging scanner. Study Hypotheses:

1. 1.compared to non-ADHD smokers, smokers with ADHD will exhibit greater abstinence-induced decrements in response inhibition performance and reward and greater concomitant disruptions of brain activity
2. 2.administration of MPH to abstinent smokers will ameliorate response inhibition performance and reward deficits and task-related brain activation and this effect will be greater among ADHD smokers
3. 3.genetic markers of dopamine neurotransmission will moderate abstinence- and MPH - induced changes in task-related brain activation across tasks.

Conditions

Smoking; ADHD

Keywords

Smoking; ADHD; Nicotine; Methylphenidate; function Magnetic Resonance Imaging; Neurobiological basis of abstinence-induced deficits in response inhibition

Outcome Measures

Primary Outcomes (1)

• To evaluate the effects of smoking abstinence on response inhibition brain function in smokers with and without ADHD.

  Smokers will undergo three functional Magnetic Resonance Image scanning sessions while performing a task that measures response inhibition (Go/Go/No-Go task) Scanning will take place in the following conditions: smoking as usual + placebo pill, 24 hr smoking abstinence + placebo pill and 24 hr abstinence + methylphenidate (MPH). Methylphenidate is a dopamine reuptake inhibitor and its administration will allow us to evaluate the role of dopamine neurotransmission on response inhibition in the context of smoking abstinence.

  July 2009 through December 2013

Study Arms (1)

ADHD and non-ADHD Smokers

Those that are defined as regular smokers (10 cigarettes/day or Carbon Monoxide reading of 10 ppm). The group will then be split into those diagnosed with ADHD/ADD and controls for comparison.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

120 voluntary participants to yield 40 Adult Regular Smokers, including 20 diagnosed with ADHD and 20 comparison controls.

You may qualify if:

• generally healthy, between the ages of 18-50yrs,
• smoking at least 10 cigarettes/day of a brand delivering ≥0.5 mg nicotine according to the standard Federal Trade Commission (FTC) method,
• an expired Carbon Monoxide concentration of at least 10ppm (to confirm inhalation) or a positive urine cotinine test (Nicalert ™) of 3 or greater,
• no interest in quitting smoking as measured by self-report,
• right-handed as measured by a three item scale used in our laboratory.

You may not qualify if:

• unable to attend all required experimental sessions,
• have significant health problems (e.g., chronic hypertension, emphysema, seizure disorders, history of significant heart problems),
• use of psychoactive medications with the exception of ADHD pharmacotherapies among ADHD diagnosed participants (see washout procedures below)
• use of smokeless tobacco
• current or past year alcohol or drug abuse,
• use of illegal drugs as measured by urine drug screen or self report
• current use of nicotine replacement therapy or other smoking cessation treatment,
• presence of conditions that would make MRI unsafe (e.g., pacemaker, metal objects in the body, IUD),
• if they are female and pregnant or plan on becoming pregnant.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke Child and Family Study Center//Duke Health Behavior Neuroscience Research Program

Durham, North Carolina, 27705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples With DNA

MeSH Terms

Conditions

Smoking; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Francis J McClernon, Ph.D.

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 14, 2010
• Study Start: July 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 8, 2018

Record last verified: 2014-08

Locations

US (1)