Attention Deficit Hyperactivity DisorderPhase 4NCT01207622
Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder and Substance Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD) with comorbid Substance Use Disorder (SUD). Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Substance Use Disorder
- What is being tested?
- Atomoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female outpatients 15-30 years.
- Subjects with a DSM-IV diagnosis of ADHD (combined or inattentive subtype) as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
- Subjects with a current or recent (within three months) substance use disorder (drugs or alcohol) as determined through clinical evaluation and/or ascertained through structured diagnostic interview.
- Subjects with an ADHD CGI-S of >= 4 (moderate impairment).
Who cannot join
- Pregnant or nursing females.
- Subjects with a clinically unstable medical condition that will either jeopardize patient safety or affect the scientific merit of the study, or who undergo a change in treatment during the study.
- Recent history of intravenous drug use, or subjects who have current DSM-IV criteria for abuse or dependence of cocaine, MDA, MDMA, gammahydroxybutyrate, methamphetamines, amphetamines, opioids, PCP, or benzodiazepines that in the opinion of the investigator will interfere in their ability to participate safely in the study.
- Subjects with Mental Retardation or Organic Brain Syndromes.
- Subjects who are psychotic or have a history of bipolar disorder.
- Participants who are taking any psychotropic or anti-SUD medications will be excluded from the study.
- Current DSM-IV diagnosis of major depression, depressive disorders, or anorexia as manifested by clinical interviews.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD)
The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD) with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing SUD relapse.
- Being tested
- Atomoxetine, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Active comparator | Not described Receives: Drug: Atomoxetine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Timothy Wilens, MD, Massachusetts General Hospital
- Investigators
- Timothy Wilens, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207622
- Sponsor's protocol ID
- 2003-P-001823
- Other IDs
- 5K24DA016264-02
- Status last verified
- Mar 2013
- First submitted
- 22 Sep 2010
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD)
- ClinicalTrials.gov ID
- NCT01207622
- Acronym / sponsor ID
- 2003-P-001823
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- First posted
- 23 Sep 2010 (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 primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD) with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing SUD relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Active comparator | Drug: Atomoxetine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female outpatients 15-30 years.
- Subjects with a DSM-IV diagnosis of ADHD (combined or inattentive subtype) as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
- Subjects with a current or recent (within three months) substance use disorder (drugs or alcohol) as determined through clinical evaluation and/or ascertained through structured diagnostic interview.
- Subjects with an ADHD CGI-S of >= 4 (moderate impairment).
Key exclusion criteria (7 listed)
- Pregnant or nursing females.
- Subjects with a clinically unstable medical condition that will either jeopardize patient safety or affect the scientific merit of the study, or who undergo a change in treatment during the study.
- Recent history of intravenous drug use, or subjects who have current DSM-IV criteria for abuse or dependence of cocaine, MDA, MDMA, gammahydroxybutyrate, methamphetamines, amphetamines, opioids, PCP, or benzodiazepines that in the opinion of the investigator will interfere in their ability to participate safely in the study.
- Subjects with Mental Retardation or Organic Brain Syndromes.
- Subjects who are psychotic or have a history 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 | Atomoxetine |
| Placebo | Drug | Placebo |
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 5 Mar 2013.
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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.
Timothy Wilens, 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?
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder and Substance Use Disorder, 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 4 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: withdrawn, as of the sponsor's last update on 5 Mar 2013. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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 5 Mar 2013.