Brain-imaging and Adolescent Neuroscience Consortium (BANC)
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| ClinicalTrials.gov Identifier: NCT01511679 |
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Recruitment Status
:
Withdrawn
(The project was not funded.)
First Posted
: January 19, 2012
Last Update Posted
: January 3, 2013
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Sponsor:
Boston Children’s Hospital
Collaborators:
Massachusetts General Hospital
Mclean Hospital
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Boston Children’s Hospital
- Study Details
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- No Results Posted
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Brief Summary:
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 or disease |
|---|
| Alcohol Abuse |
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 |
| Actual Enrollment : | 0 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Brain-imaging and Adolescent Neuroscience Consortium |
| Study Start Date : | September 2012 |
| Estimated Primary Completion Date : | March 2017 |
| Estimated Study Completion Date : | September 2017 |
| Group/Cohort |
|---|
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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).
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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
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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)
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Biospecimen Retention: Samples With DNA
Saliva DNA samples for future analyses.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511679
Locations
| United States, Massachusetts | |
| McLean Hospital | |
| Belmont, Massachusetts, United States, 02478 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Boston University School of Medicine | |
| Boston, Massachusetts, United States, 02118 | |
| Massachusetts Institute of Technology | |
| Cambridge, Massachusetts, United States, 02139 | |
Sponsors and Collaborators
Boston Children’s Hospital
Massachusetts General Hospital
Mclean Hospital
Massachusetts Institute of Technology
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 |
Additional Information:
| Responsible Party: | Boston Children’s Hospital |
| ClinicalTrials.gov Identifier: | NCT01511679 History of Changes |
| Other Study ID Numbers: |
BANC RFA-AA-12-006 |
| First Posted: | January 19, 2012 Key Record Dates |
| Last Update Posted: | January 3, 2013 |
| Last Verified: | January 2013 |
Keywords provided by Boston Children’s Hospital:
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Alcohol abuse |
Additional relevant MeSH terms:
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Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |