- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01093898
The Neuroeconomics of Behavioral Therapies for Adolescent Substance Abuse (Imaging)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Little is known about the role of adolescent neurodevelopment in adolescent substance abuse treatment outcomes. The development and evaluation of adolescent substance abuse treatments rarely includes consideration of varying cognitive capacities and their neural representations as determinants of individual variation in treatment response. This proposed R21 project would address this gap by identifying associations among decision making, task-related neural processing, and treatment outcome among adolescents participating/have participated in two randomized clinical trials for adolescent substance abuse. Increasing our understanding of neural processes that underlie decision making in adolescent marijuana and alcohol users would inform the development of future intervention and prevention efforts.
This complementary project draws subjects from two studies investigating contingency-management (CM) based treatments "Behavioral Treatment of Adolescent Marijuana Abuse" (DA015186), and "Family Based Contingency Management for Adolescent Alcohol Abuse" (AA016917). Both trials compare a unique CM intervention that involves an abstinence-based reinforcement program to a standard, state of the art cognitive behavioral intervention. Analyses would be performed separately for the two samples, with hypotheses tested first using the Marijuana sample, and assessed for replication/specificity using the Alcohol sample. The proposed project would explore novel neurobiological predictors of response to CM interventions.
Adolescents recruited into the Marijuana Trial (n=69; 23 per treatment arm) and the Alcohol Trial (n=54; 27 per treatment arm) during the period of this R21 project would participate in a single neuroimaging session as soon after the intake session as possible, within 7 to 30 days. During the neuroimaging session, adolescents would make intertemporal choice decisions in a Delay Discounting task regarding gains of $100 and $1,000. Preliminary data from the Marijuana trial demonstrates significant association between performance on this behavioral delay discounting task and abstinence achieved during treatment over and above the significant effect of treatment condition. The investigators seek to understand the neural processes that underlie performance on this laboratory task, and the degree to which variation in these neural processes relates to and predicts adolescent substance abuse treatment outcomes. The conceptual framework for the proposed project is based on the neuroeconomics of addiction in general, and the competing neural systems hypothesis in particular (Bechara, 2005a; Bickel, et al., 2007; Daw, et al., 2005; Jentsch & Taylor, 1999). This behavioral choice hypothesis postulates a biased competition between an "impulsive" (or ''reflexive") neural system (including the striatum, amygdala, ventral pallidum, and related structures) and the "executive" (or "reflective") neural system (including the prefrontal cortex) in understanding patterns of suboptimal decision making among substance-dependent individuals. An overarching hypothesis is that differing responses to distinct treatment approaches (CM vs. CBT) are partially determined by the pattern of activation or functional connectivity within and across these competing neural systems. These project hypotheses would be tested by the following specific aims:
Primary Aims:
- Determine the degree to which performance on a laboratory delay discounting task correlates with activity in impulsive and/or executive neural systems.
- Determine the degree to which performance on a laboratory delay discounting task and neural processing predict adolescent substance abuse treatment outcome over and above the effects of treatment condition.
Secondary Aim:
- Explore interactions between response to CM and delay discounting-related neural processing.
In summary, this proposed exploratory/developmental project would importantly contribute to the understanding of the role of neural processing in adolescent substance-abuse treatment processes and outcome. Specifically, this study has the potential to reveal relations among decision making, neural processing, and treatment outcomes, including the role of patterns of neural activation on response to contingency management among adolescent substance abusers. Results will have implications for future research on adolescent neurodevelopment and adolescent substance abuse treatment. The potential to use neuroscience findings to better understand and improve treatment outcomes in substance-abusing adolescents will have strong public health impact.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Geisel School of Medicine at Dartmouth
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Participants must be 12 to 18 years old and have a parent/guardian who can participate.
Youth must meet either of the following inclusion criteria:
- Report using marijuana during the previous 30 days or provide a marijuana-positive urine test, plus meet criteria for Cannabis Abuse or Dependence OR
- Meet Diagnostic Statistical Manual (DSM) criteria for Alcohol Abuse or dependence or have had one binge episode, specified by ≥5 drinks in one day, in the past 90 days and report alcohol use in the past 30 days.
Exclusion Criteria:
- Contraindications to MRI including ferromagnetic implants or claustrophobia
- Meeting DSM criteria for dependence on illicit drugs other than marijuana or alcohol (use/abuse of other drugs will not be excluded)
- Exhibit active psychosis, have severe medical or psychiatric illness limiting participation
- Are pregnant or breast-feeding.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Aucune intervention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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delay discounting
Délai: Assessed at baseline
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laboratory task assessing preference for immediate rewards
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Assessed at baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Catherine Stanger, Ph.D., Dartmouth College
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 36824
- 1R21DA029442-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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