NCT01511679

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

4.5 years

First QC Date

January 13, 2012

Last Update Submit

January 2, 2013

Conditions

Keywords

Alcohol abuse

Study Arms (3)

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)

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva DNA samples for future analyses.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 19, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations