Attention Deficit Hyperactivity Disorder, Substance Abuse
Conditions
Keywords
Adolescent, ADHD, SUD
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.
Interventions
DRUGAtomoxetine
Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder
DRUGPlacebo
Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder
Sponsors
American Academy of Child Adolescent Psychiatry.
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Line Followback Interview (TLFB) | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo The participants received placebo plus CBT for their substance use disorder for 12 weeks. | 35 |
| 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. | 35 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Atomoxetine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 31 Participants | 64 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Continuous | 16.06 years STANDARD_DEVIATION 1.35 | 16.11 years STANDARD_DEVIATION 1.78 | 16.09 years STANDARD_DEVIATION 1.56 |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 25 Participants | 30 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 35 | 23 / 35 |
| serious Total, serious adverse events | 1 / 35 | 1 / 35 |
Outcome results
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.
Time frame: baseline and weekly through week 12 post randomization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist | 18.61 units on a scale |
| Atomoxetine | Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist | 18.19 units on a scale |
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.
Time frame: weekly from randomization to 12 weeks post-randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Side Effect Form for Children and Adolescents (SEFCA) | 1 Number of serious adverse events |
| Atomoxetine | Side Effect Form for Children and Adolescents (SEFCA) | 1 Number of serious adverse events |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Time Line Followback Interview (TLFB) | -2.24 days |
| Atomoxetine | Time Line Followback Interview (TLFB) | -5.78 days |