ADHDNCT00181792
Family Risk Analysis of Substance Use in Attention Deficit Hyperactivity Disorder (ADHD) Youth Treated With Concerta
An observational study of ADHD and Smoking, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 55 yearsHealthy volunteers can take part
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Aug 2009
- 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 6 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: Family Risk Analysis of Substance Use in ADHD Youth Treated With Concerta
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.
Read the 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:
- assessment of psychopathology and substance use/dependence,
- assessment of the family environment, and
- 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.
- Keywords
- ADHD, smoking, familial risk
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Family based
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Hammerness, MD, Massachusetts General Hospital
- Investigators
- Paul Hammerness, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181792
- Sponsor's protocol ID
- 2005-P-000278
- Status last verified
- May 2012
- First submitted
- 13 Sep 2005
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Risk Analysis of Substance Use in ADHD Youth Treated With Concerta
- ClinicalTrials.gov ID
- NCT00181792
- Acronym / sponsor ID
- 2005-P-000278
- Keywords
- ADHD, smoking, familial risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Sep 2005 (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.
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.
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:
- assessment of psychopathology and substance use/dependence,
- assessment of the family environment, and
- 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
- Observational model
- Family based
Who may qualify
- Ages
- 6 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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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.
Paul Hammerness, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD and Smoking, run by Massachusetts General Hospital at 1 site 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 4 May 2012.