Brain-imaging and Adolescent Neuroscience Consortium

NCT ID: NCT01511679

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-09-30

Brief Summary

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This is a multi-site study of adolescents 12-21 years-of-age to evaluate the long and shorter-term effect of adolescent alcohol use on the developing brain.

Detailed Description

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The overall specific aims of this study are to: 1) assess the short and long-term consequences of alcohol exposure on brain, cognitive, and emotional/regulatory development during preadolescence and adolescence; 2) determine the effects of timing, dose, and duration of alcohol on brain and cognitive development; 3) assess recovery of neural and behavioral function to determine if the plasticity of the adolescent brain makes it more or less vulnerable to alcohol's acute and chronic effects; 4) understand how other key covariates (e.g., existing or emerging psychopathology, family history of alcoholism, demographics, pubertal development) factor into alcohol's effects on the brain; and 5) identify early neural, cognitive, and affective markers that may predict alcohol abuse and dependence during adolescence and/or adulthood.

Conditions

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Alcohol Abuse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alcohol-naive adolescents

A general population longitudinal cohort of alcohol-naïve (or h/o minimal recent-onset drinking) adolescents in three specific age-groups: early (12-14 y/o), middle (15-17 y/o), and late (18-21 y/o).

No interventions assigned to this group

Treatment sample

A sample of adolescents who have a \>1 year history of heavy drinking but have agreed to stop drinking as part of their treatment plan

No interventions assigned to this group

High risk sample

High-risk adolescents who have a family history of alcohol-use disorder and other risk factors (symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD), Conduct Disorder, or Mood Disorder)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* able to read and understand English
* available for follow-up
* parental consent/adolescent assent for those 12-17 years
* consent for those 18-21 years

Exclusion Criteria

* Weight \> 300 lbs
* braces or unremovable embedded metal
* claustrophobia or inability to lie still in MRI machine
* current or past 12-mos pregnancy (females)
* requires urgent medical/mental health care
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role collaborator

Massachusetts Institute of Technology

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John R Knight, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Gordon J Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Simon Warfield, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Avram Holmes, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Scott Lukas, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Marisa Silveri, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Marlene Oscar Berman, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

John Gabrieli, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Institute of Technology

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.ceasar.org

Center for Adolescent Substance Abuse Research at Children's Hospital Boston

Other Identifiers

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BANC RFA-AA-12-006

Identifier Type: -

Identifier Source: org_study_id

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