Back to resultsAtomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder
Primary Purpose
Attention Deficit Hyperactivity Disorder, Substance Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Adolescent, ADHD, SUD
Eligibility Criteria
Inclusion Criteria:
- Age 12-19
- Provided assent/consent
- attention-deficit hyperactivity disorder (ADHD) by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
- Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) checklist <=22
- At least one non-nicotine substance use disorder (SUD) by KSADS
- Plans to live locally for 4 months
- Willing to participate in cognitive behavioral therapy (CBT)
Exclusion Criteria:
- No mental illness that cannot be managed as an outpatient or without concurrent psychotropic medication
- No allergy to atomoxetine
- No narrow angle glaucoma
- No serious medical illness
- Not pregnant
- Not unwilling to use an effective form of contraception during the trial
- No SUD that cannot be managed as an outpatient or without concurrent psychotropic medication
Sites / Locations
- Denver Health Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
placebo plus individual cognitive behavioral therapy
atomoxetine plus individual cognitive behavioral therapy
Outcomes
Primary Outcome Measures
Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
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.
Secondary Outcome Measures
Time Line Followback Interview (TLFB)
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)
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.
Full Information
NCT ID
NCT00399763
First Posted
November 13, 2006
Last Updated
June 12, 2015
Sponsor
Denver Health and Hospital Authority
Collaborators
American Academy of Child Adolescent Psychiatry.
1. Study Identification
Unique Protocol Identification Number
NCT00399763
Brief Title
Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder
Official Title
A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
American Academy of Child Adolescent Psychiatry.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out whether atomoxetine (also called Strattera) helps teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol problems.
Detailed Description
Evidence-based psychosocial treatments have recently been developed. However, very little data exist on the use of pharmacotherapy for adolescents SUD (Substance Use Disorder). One promising pharmacotherapy approach is to treat co-occuring psychiatric disorders. A common co-occurring disorder in adolescent SUD is attention-deficit/hyperactivity disorder (ADHD). Fortunately, new ADHD medications, such as atomoxetine, that do not have addictive potential are now available. However, all controlled studies of atomoxetine have specifically excluded teens with SUD. Therefore, little data exist on the safety and efficacy of the medication in this population. This research project will address the important research gap with the specific aim: to conduct a randomized, placebo-controlled trial of atomoxetine for ADHD in teens with SUD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Substance Abuse
Keywords
Adolescent, ADHD, SUD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo plus individual cognitive behavioral therapy
Arm Title
2
Arm Type
Experimental
Arm Description
atomoxetine plus individual cognitive behavioral therapy
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder
Primary Outcome Measure Information:
Title
Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
Description
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 Frame
baseline and weekly through week 12 post randomization
Secondary Outcome Measure Information:
Title
Time Line Followback Interview (TLFB)
Description
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.
Time Frame
12 weeks
Title
Side Effect Form for Children and Adolescents (SEFCA)
Description
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.
Time Frame
weekly from randomization to 12 weeks post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 12-19
Provided assent/consent
attention-deficit hyperactivity disorder (ADHD) by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) checklist <=22
At least one non-nicotine substance use disorder (SUD) by KSADS
Plans to live locally for 4 months
Willing to participate in cognitive behavioral therapy (CBT)
Exclusion Criteria:
No mental illness that cannot be managed as an outpatient or without concurrent psychotropic medication
No allergy to atomoxetine
No narrow angle glaucoma
No serious medical illness
Not pregnant
Not unwilling to use an effective form of contraception during the trial
No SUD that cannot be managed as an outpatient or without concurrent psychotropic medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian C Thurstone, MD
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20494267
Citation
Thurstone C, Riggs PD, Salomonsen-Sautel S, Mikulich-Gilbertson SK. Randomized, controlled trial of atomoxetine for attention-deficit/hyperactivity disorder in adolescents with substance use disorder. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):573-82. doi: 10.1016/j.jaac.2010.02.013.
Results Reference
derived
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Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder
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