We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Family Risk Analysis of Substance Use in Attention Deficit Hyperactivity Disorder (ADHD) Youth Treated With Concerta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00181792
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 4, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The researchers will study 100 families over three years, each with a child (proband) between the ages of 12-17, with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of ADHD. The researchers hypothesize smoking will be familial and ADHD probands with a family history of tobacco use will be at increased risk for early initiation and persistence of smoking, compared to ADHD probands with no family history of tobacco use.

Condition or disease Phase
ADHD Smoking Phase 4

Detailed Description:

As Attention Deficit Hyperactivity Disorder (ADHD) is a documented risk factor for smoking in adolescents, and as theoretical considerations suggest that ADHD and tobacco use may share common underlying mechanisms, the proposed study looks to examine the association between smoking and ADHD. Since both ADHD and smoking are known to be familial disorders, one approach to examine the nature of the association between the two disorders is to conduct a familial risk analysis comparing ADHD youth who smoke and ADHD youth who don't smoke. Another approach is to conduct a genetic study, to identify candidate genes associated with nicotine abuse and dependence in ADHD youth and relatives.

This study includes:

  1. assessment of psychopathology and substance use/dependence,
  2. assessment of the family environment, and
  3. assessment of molecular genetics in 100 families with at least one child (proband) between the ages of 12-17 with a DSM-IV diagnosis of ADHD.

Study Design

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Family-Based
Official Title: Family Risk Analysis of Substance Use in ADHD Youth Treated With Concerta
Study Start Date : May 2005
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   6 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
First-degree relative between the ages of 6-55 years of a family member (proband) between the ages of 12-17 with the DSM-IV diagnosis of ADHD

Inclusion Criteria:

  • First-degree relative between the ages of 6-55 years of a family member (proband) between the ages of 12-17 with the DSM-IV diagnosis of ADHD
Contacts and Locations

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): NCT00181792

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Paul Hammerness, MD Massachusetts General Hospital
More Information

Responsible Party: Paul Hammerness, MD, Assistant Professor Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181792     History of Changes
Other Study ID Numbers: 2005-P-000278
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Paul Hammerness, MD, Massachusetts General Hospital:
familial risk

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents