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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01511679
Other study ID # BANC RFA-AA-12-006
Secondary ID
Status Withdrawn
Phase N/A
First received January 13, 2012
Last updated January 2, 2013
Start date September 2012
Est. completion date September 2017

Study information

Verified date January 2013
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 21 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts
United States Boston University School of Medicine Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Massachusetts Institute of Technology Cambridge Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Children's Hospital Boston Massachusetts General Hospital, Massachusetts Institute of Technology, Mclean Hospital

Country where clinical trial is conducted

United States, 

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