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Brain-imaging and Adolescent Neuroscience Consortium (BANC)

This study has been withdrawn prior to enrollment.
(The project was not funded.)
Sponsor:
Collaborators:
Massachusetts General Hospital
Mclean Hospital
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01511679
First received: January 13, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Alcohol Abuse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain-imaging and Adolescent Neuroscience Consortium

Further study details as provided by Children's Hospital Boston:

Biospecimen Retention:   Samples With DNA

Saliva DNA samples for future analyses.
Enrollment: 0
Study Start Date: September 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.

  Eligibility
Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511679

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Children's Hospital Boston
Massachusetts General Hospital
Mclean Hospital
Massachusetts Institute of Technology
Investigators
Principal Investigator: John R Knight, MD Children's Hospital Boston
Principal Investigator: Gordon J Harris, PhD Massachusetts General Hospital
Principal Investigator: Simon Warfield, PhD Children's Hospital Boston
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
  More Information

Additional Information:
Center for Adolescent Substance Abuse Research at Children's Hospital Boston  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01511679     History of Changes
Other Study ID Numbers: BANC RFA-AA-12-006
Study First Received: January 13, 2012
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Alcohol abuse

ClinicalTrials.gov processed this record on March 02, 2015