- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01624428
Varenicline on Reward Responses and Cognition in Adolescent Smokers (GRAND)
30. januar 2014 opdateret af: Yale University
Examining the Effects of Varenicline on Reward Responses,Cognition, and Tobacco Cues in Adolescent Smokers
This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the influence of varenicline on reward processing, cognitive control, and regulation of craving in adolescent smokers.
We hypothesize that adolescent smokers receiving varenicline, when compared with those receiving placebo, will have differential brain responses to anticipation of rewards, during exposure to the Stroop task, and in response to tobacco cues.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the influence of varenicline on reward processing, cognitive control, and regulation of craving in adolescent smokers.
We hypothesize that adolescent smokers receiving varenicline, when compared with those receiving placebo, will have increased activation of the ventral striatum (VS) in response to anticipation of rewards in the Monetary Incentive Delay Task (MIDT), decreased activation of the dorsolateral prefrontal cortex (dlPFC) during exposure to incongruent stimuli in the Stroop task, and reduced activation of the ventral striatum in response to tobacco cues, and increased activation of the dlPFC during regulation of responses to tobacco cues during the Regulation of Craving (ROC) task.
The results of this pilot project will have important implications regarding the use of varenicline for treating tobacco dependence and understanding varenicline's neurobiological effects in adolescent smokers.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
16
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06519
- Substance Abuse Center
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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
16 år til 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Between 16-19 years of age
- Able to read and write English
- Smoking 5 or more cigarettes on a daily basis, for at least one year
- Not seeking smoking cessation treatment
- Weighing > 55 kg (121 lbs)
Exclusion Criteria:
- Current criteria for abuse or dependence on another psychoactive substance.
- Current diagnosis of any clinical significant psychiatric disease like major depressive disorder, panic or anxiety disorder, psychosis, schizophrenia, bipolar disorder.
- Those with a prior suicide attempt or with active suicidal ideation at baseline
- Any regular use of any psychoactive drugs including anxiolytics and antidepressants
- Pregnant or lactating girls: females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least 14 days prior to study medication administration until 30 days after the last dose of study medication. Acceptable methods of contraception are: abstinence; any form of hormonal contraception such as Depo-Provera, daily oral contraceptive, transdermal patch, or Nuva-ring; intra-uterine device, sterilization; or double barrier contraception which is a combination of any two of the following methods: condoms, spermicide, diaphragm.
- Evidence or history of clinically significant neurological, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or allergic disease.
- History of prior use of or sensitivity to varenicline.
- Color-blindness
- History of significant head trauma
- Metal in body
- Other medical conditions contra-indicated for MRI
- Past history of marked irritability or agitation when attempting to quit smoking, determined by the Minnesota Nicotine Withdrawal Questionnaire.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo
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1 mg bid placebo titrated over a 2 week period
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Aktiv komparator: vareniclin
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1 mg bid varenicline titrated over a 2 week period
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
neural responses to the MIDT
Tidsramme: During MRI following14 days of varenicline treatment
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The Monetary Incentive Delay Task (MIDT) will be administered during the fMRI at the end of 14 days of varenicline treatment
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During MRI following14 days of varenicline treatment
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neural responses to the ROC
Tidsramme: During MRI following14 days of varenicline treatment
|
The Regulation of Craving (ROC)will be administered during the fMRI at the end of 14 days of varenicline treatment
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During MRI following14 days of varenicline treatment
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neural responses to the Stroop
Tidsramme: During MRI following14 days of varenicline treatment
|
The Stroop will be administered during the fMRI at the end of 14 days of varenicline treatment
|
During MRI following14 days of varenicline treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. juni 2012
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
18. juni 2012
Først indsendt, der opfyldte QC-kriterier
19. juni 2012
Først opslået (Skøn)
20. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1108008929
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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-
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