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

7. november 2018 opdateret af: Duke University

Neuropharmacology of Response Inhibition in Comorbid ADHD and Nicotine Dependence

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

During the study, 101 subjects signed consents and 38 subjects completed the study.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

101

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Duke Child and Family Study Center//Duke Health Behavior Neuroscience Research Program

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the effects of smoking abstinence on response inhibition brain function in smokers with and without ADHD.
Tidsramme: July 2009 through December 2013
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Francis J McClernon, Ph.D., Duke Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2009

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

12. maj 2010

Først indsendt, der opfyldte QC-kriterier

13. maj 2010

Først opslået (Skøn)

14. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2018

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Pro00009085
  • 1R01DA024838-01A1 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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