Alcohol AbuseBANCNCT01511679
Brain-imaging and Adolescent Neuroscience Consortium
An observational study of Alcohol Abuse, run by Boston Children's Hospital at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Alcohol Abuse
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2012to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female adolescents 12-21 years-of-age presenting for care at one of the participating medical clinics
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
McLean Hospital
Belmont, Massachusetts, 02478
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University School of Medicine
Boston, Massachusetts, 02118
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
About this study
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.
Read the 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.
- Conditions
- Alcohol Abuse
- Keywords
- Alcohol abuse
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: The project was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Mclean Hospital, Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- John R Knight, MD, Principal investigator, Boston Children's HospitalGordon J Harris, PhD, Principal investigator, Massachusetts General HospitalSimon Warfield, PhD, Principal investigator, Boston Children's HospitalAvram Holmes, PhD, Principal investigator, Harvard UniversityScott Lukas, PhD, Principal investigator, Mclean HospitalMarisa Silveri, PhD, Principal investigator, Mclean HospitalMarlene Oscar Berman, PhD, Principal investigator, Boston UniversityJohn Gabrieli, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511679
- Sponsor's protocol ID
- BANC RFA-AA-12-006
- Acronym
- BANC
- Status last verified
- Jan 2013
- First submitted
- 13 Jan 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-imaging and Adolescent Neuroscience Consortium
- ClinicalTrials.gov ID
- NCT01511679
- Acronym / sponsor ID
- BANC / BANC RFA-AA-12-006
- Conditions
- Alcohol Abuse
- Keywords
- Alcohol abuse
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The project was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Mclean Hospital, Massachusetts Institute of Technology
- Study start
- Sep 2012
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female adolescents 12-21 years-of-age presenting for care at one of the participating medical clinics
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Center for Adolescent Substance Abuse Research at Children's Hospital BostonLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Knight, MD principal investigator
Boston Children's Hospital
Gordon J Harris, PhD principal investigator
Massachusetts General Hospital
Simon Warfield, PhD principal investigator
Boston Children's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Abuse, run by Boston Children's Hospital at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013; AzTrials last refreshed its copy on 30 Oct 2026.