Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder

This study has been completed.
Sponsor:
Collaborator:
American Academy of Child Adolescent Psychiatry.
Information provided by (Responsible Party):
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00399763
First received: November 13, 2006
Last updated: June 12, 2015
Last verified: June 2015
Results First Received: August 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
Substance Abuse
Interventions: Drug: Atomoxetine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo The participants received placebo plus CBT for their substance use disorder for 12 weeks.
Atomoxetine The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.

Participant Flow:   Overall Study
    Placebo     Atomoxetine  
STARTED     35     35  
COMPLETED     33     32  
NOT COMPLETED     2     3  
Lost to Follow-up                 2                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo The participants received placebo plus CBT for their substance use disorder for 12 weeks.
Atomoxetine The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
Total Total of all reporting groups

Baseline Measures
    Placebo     Atomoxetine     Total  
Number of Participants  
[units: participants]
  35     35     70  
Age  
[units: participants]
     
<=18 years     31     33     64  
Between 18 and 65 years     4     2     6  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  16.11  (1.78)     16.06  (1.35)     16.09  (1.56)  
Gender  
[units: participants]
     
Female     5     10     15  
Male     30     25     55  
Region of Enrollment  
[units: participants]
     
United States     35     35     70  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Time Line Followback Interview (TLFB)   [ Time Frame: 12 weeks ]

3.  Secondary:   Side Effect Form for Children and Adolescents (SEFCA)   [ Time Frame: weekly from randomization to 12 weeks post-randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. The study was not powered to assess safety.
  2. Participants received individual motivational interviewing/cognitive behavioral therapy for substance treatment. The results may not generalize to samples receiving different behavioral treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christian Thurstone, M.D.
Organization: Denver Health
phone: 303-436-6006
e-mail: christian.thurstone@dhha.org


No publications provided by Denver Health and Hospital Authority

Publications automatically indexed to this study:

Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT00399763     History of Changes
Other Study ID Numbers: 05-0563
Study First Received: November 13, 2006
Results First Received: August 3, 2012
Last Updated: June 12, 2015
Health Authority: United States: Institutional Review Board