Trial record 22 of 122 for:    ADHD | Open Studies | United States | Child, Adult

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01123668
First received: May 12, 2010
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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. 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. 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. genetic markers of dopamine neurotransmission will moderate abstinence- and MPH - induced changes in task-related brain activation across tasks.

Condition
Smoking
ADHD

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neuropharmacology of Response Inhibition in Comorbid ADHD and Nicotine Dependence

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To evaluate the effects of smoking abstinence on response inhibition brain function in smokers with and without ADHD. [ Time Frame: July 2009 through December 2013 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Samples With DNA


Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Individuals diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) smoke more than the general population, initiate use at a younger age, and report more difficulty trying to quit. The overarching goal of the present application is to use neuroimaging, neuropharmacological and molecular genetic techniques to study the neurobiological basis of abstinence-induced deficits in response inhibition in ADHD and non-ADHD smokers. Twenty smokers with ADHD and 20 smokers without ADHD will undergo imaging during a Go/No-Go task under the following conditions: 1) smoking as usual, 2) 24 hr smoking abstinence, and 3) 24 hr smoking abstinence + methylphenidate (MPH). We hypothesize that compared to smoking as usual, 24 hr smoking abstinence will result in decrements in response inhibition and disruption of task-related brain activation. These effects will be greater in ADHD as compared to non-ADHD smokers. We further hypothesize that MPH administration during abstinence will restore performance and brain indices of response inhibition and that the magnitude of the effect of MPH will be greater among smokers with ADHD. In addition to the above aims, we will preliminarily evaluate the moderating effects of the dopamine receptor D4 7-repeat allele on task-related brain activation following smoking abstinence and MPH administration.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. unable to attend all required experimental sessions,
  2. have significant health problems (e.g., chronic hypertension, emphysema, seizure disorders, history of significant heart problems),
  3. use of psychoactive medications with the exception of ADHD pharmacotherapies among ADHD diagnosed participants (see washout procedures below)
  4. use of smokeless tobacco
  5. current or past year alcohol or drug abuse,
  6. use of illegal drugs as measured by urine drug screen or self report
  7. current use of nicotine replacement therapy or other smoking cessation treatment,
  8. presence of conditions that would make MRI unsafe (e.g., pacemaker, metal objects in the body, IUD),
  9. if they are female and pregnant or plan on becoming pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123668

Contacts
Contact: Joseph S English, M.Env.Mgmt. 919-681-0028 engli009@mc.duke.edu
Contact: Nicole K Kaiser, B.A. 919-684-1333 nicole.kaiser@dm.duke.edu

Locations
United States, North Carolina
Duke Child and Family Study Center//Duke Health Behavior Neuroscience Research Program Recruiting
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Francis J McClernon, Ph.D. Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01123668     History of Changes
Other Study ID Numbers: Pro00009085, 1R01DA024838-01A1
Study First Received: May 12, 2010
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Smoking
ADHD
Nicotine
Methylphenidate
function Magnetic Resonance Imaging
Neurobiological basis of abstinence-induced deficits in response inhibition

Additional relevant MeSH terms:
Tobacco Use Disorder
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on August 26, 2014