Substance Use DisordersPhase 2NCT00029614
Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD
A Phase 2 study testing Atomoxetine in people with Substance Use Disorders and Attention Deficit Hyperactivity Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Substance Use Disorders, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jul 2007
- Phase
- Phase 2
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents, ages 13-18
- Meets criteria for alcohol and/or substance use disorder and attention deficit hyperactivity disorder.
Who cannot join
- Adolescents who are pregnant.
- Have a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk.
- History of pervasive development disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders.
- Currently on other psychotropic medications from which discontinuation would present a significant risk.
- A current episode of major depressive disorder or a diagnosis of bipolar disorder.
- Diagnosis of dependence for any substance other than marijuana.
- Adolescents with a full-scale IQ below 80.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Psychopharmacology of Adolescents With AUD and ADHD
The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).
- Being tested
- Atomoxetine
- Keywords
- ADHD, Substance Use
- Medical subject headings
- Substance-Related Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in ADHD symptoms
decrease in the quantity and frequency of alcohol and other substance use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2002 (estimated)
- Study startMay 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Oscar G. Bukstein, MD, Principal investigator, Western Psychiatric Institute and Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029614
- Sponsor's protocol ID
- NIAAABUK00301
- Other IDs
- K24AA000301, NIH Grant 5K24AA000301-05
- Status last verified
- Apr 2010
- First submitted
- 16 Jan 2002
- Last updated
- 28 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychopharmacology of Adolescents With AUD and ADHD
- ClinicalTrials.gov ID
- NCT00029614
- Acronym / sponsor ID
- NIAAABUK00301
- Keywords
- ADHD, Substance Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Jan 2002 (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 purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents, ages 13-18
- Meets criteria for alcohol and/or substance use disorder and attention deficit hyperactivity disorder.
Key exclusion criteria (7 listed)
- Adolescents who are pregnant.
- Have a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk.
- History of pervasive development disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders.
- Currently on other psychotropic medications from which discontinuation would present a significant risk.
- A current episode of major depressive disorder or a diagnosis of bipolar disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atomoxetine | Drug | – |
Primary outcome
decrease in ADHD symptoms
decrease in the quantity and frequency of alcohol and other substance use
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 28 Apr 2010.
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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.
Oscar G. Bukstein, MD principal investigator
Western Psychiatric Institute and Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atomoxetine in people with Substance Use Disorders and Attention Deficit Hyperactivity Disorder, run by University of Pittsburgh 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 2 inclusion and 7 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 28 Apr 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
decrease in ADHD symptoms. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 28 Apr 2010.