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| Name | Class |
|---|---|
| American Academy of Child Adolescent Psychiatry. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | placebo plus individual cognitive behavioral therapy |
|
| 2 | Experimental | atomoxetine plus individual cognitive behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and weekly through week 12 post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian C Thurstone, MD | Denver Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20494267 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The participants received placebo plus CBT for their substance use disorder for 12 weeks. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The participants received placebo plus CBT for their substance use disorder for 12 weeks. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and weekly through week 12 post randomization |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | The participants received placebo plus CBT for their substance use disorder for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suicide attempt | Psychiatric disorders | Systematic Assessment | One participant on placebo attempted to shoot himself with a revolver. There was no bullet in the chamber. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| difficulty concentrating | Psychiatric disorders | Systematic Assessment | Participants reporting difficulty with focusing. |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian Thurstone, M.D. | Denver Health | 303-436-6006 | christian.thurstone@dhha.org |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder |
|
| 12 weeks |
| 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. | weekly from randomization to 12 weeks post-randomization |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | days | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Number | Number of serious adverse events | weekly from randomization to 12 weeks post-randomization |
|
|
|
| 1 |
| 35 |
| 16 |
| 35 |
| EG001 | 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. | 1 | 35 | 23 | 35 |
|
| Overdose | Nervous system disorders | Non-systematic Assessment | One participant on atomoxetine took an overdose of bupropion tablets because he was told he could hallucinate by doing so. He had a seizure, which was treated in a local emergency room. |
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