Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder
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|ClinicalTrials.gov Identifier: NCT00399763|
Recruitment Status : Completed
First Posted : November 15, 2006
Results First Posted : July 8, 2015
Last Update Posted : July 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder Substance Abuse||Drug: Atomoxetine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Placebo Comparator: 1
placebo plus individual cognitive behavioral therapy
Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder
atomoxetine plus individual cognitive behavioral therapy
Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder
Other Name: Strattera
- Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist [ Time Frame: baseline and weekly through week 12 post randomization ]All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis.
- Time Line Followback Interview (TLFB) [ Time Frame: 12 weeks ]The TLFB assesses the number of days in which a substance was used in the past 28 days. The TLFB is administered by the clinician and uses a 28-day calendar with anchor points to record this information. This instrument relies on confidential self-report of the adolescent participant. The result is reported as mean change in the number of days used substances in the past 28 days from baseline to the end of treatment using linear mixed models in an intent-to-treat analysis.
- Side Effect Form for Children and Adolescents (SEFCA) [ Time Frame: weekly from randomization to 12 weeks post-randomization ]The SEFCA is a clinician-administered instrument that systematically assesses 52 possible side effects and rates them on a scale of 0 (not present) to 3 (severe). The instrument relies on confidential, self-report of the adolescent.The number of serious adverse events was recorded by intervention assignment.
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): NCT00399763
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Christian C Thurstone, MD||Denver Health|