Brain-imaging and Adolescent Neuroscience Consortium (BANC)
This study has been withdrawn prior to enrollment.
(The project was not funded.)
Sponsor:
Boston Children’s Hospital
Collaborators:
Massachusetts General Hospital
Mclean Hospital
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Boston Children’s Hospital
ClinicalTrials.gov Identifier:
NCT01511679
First received: January 13, 2012
Last updated: January 2, 2013
Last verified: January 2013
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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 |
|---|
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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 Boston Children’s Hospital:
Biospecimen Retention: Samples With DNA
Detailed Description:
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).
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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
|
|
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 (Child, Adult) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
| Responsible Party: | Boston Children’s Hospital |
| 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 Boston Children’s Hospital:
|
Alcohol abuse |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 30, 2016