Brain-imaging and Adolescent Neuroscience Consortium (BANC)

January 2, 2013 updated by: Boston Children's Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
      • Cambridge, Massachusetts, United States, 02139
        • Massachusetts Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female adolescents 12-21 years-of-age presenting for care at one of the participating medical clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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).
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Massachusetts General Hospital
Massachusetts Institute of Technology
Mclean Hospital

Investigators

  • Principal Investigator: John R Knight, MD, Boston Children's Hospital
  • Principal Investigator: Gordon J Harris, PhD, Massachusetts General Hospital
  • Principal Investigator: Simon Warfield, PhD, Boston Children's Hospital
  • Principal Investigator: Avram Holmes, PhD, Harvard University
  • Principal Investigator: Scott Lukas, PhD, McLean Hospital
  • Principal Investigator: Marisa Silveri, PhD, McLean Hospital
  • Principal Investigator: Marlene Oscar Berman, PhD, Boston University
  • Principal Investigator: John Gabrieli, PhD, Massachusetts Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BANC RFA-AA-12-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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