Trial Outcomes & Findings for Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (NCT NCT00399763)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

baseline and weekly through week 12 post randomization

Results posted on

2015-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	35	35
Overall Study COMPLETED	33	32
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=35 Participants The participants received placebo plus CBT for their substance use disorder for 12 weeks.	Atomoxetine n=35 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.	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	16.11 years STANDARD_DEVIATION 1.78 • n=5 Participants	16.06 years STANDARD_DEVIATION 1.35 • n=7 Participants	16.09 years STANDARD_DEVIATION 1.56 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	25 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants The participants received placebo plus CBT for their substance use disorder for 12 weeks.	Atomoxetine n=35 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.
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 Interval 15.13 to 22.08	18.19 units on a scale Interval 13.41 to 22.97

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants The participants received placebo plus CBT for their substance use disorder for 12 weeks.	Atomoxetine n=35 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.
Time Line Followback Interview (TLFB)	-2.24 days Interval -5.67 to 1.18	-5.78 days Interval -9.21 to 2.35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants The participants received placebo plus CBT for their substance use disorder for 12 weeks.	Atomoxetine n=35 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.
Side Effect Form for Children and Adolescents (SEFCA)	1 Number of serious adverse events	1 Number of serious adverse events

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Atomoxetine

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=35 participants at risk The participants received placebo plus CBT for their substance use disorder for 12 weeks.	Atomoxetine n=35 participants at risk 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.
Psychiatric disorders suicide attempt	2.9% 1/35 • Number of events 1	0.00% 0/35
Nervous system disorders Overdose	0.00% 0/35	2.9% 1/35 • Number of events 1

Other adverse events

Other adverse events
Measure	Placebo n=35 participants at risk The participants received placebo plus CBT for their substance use disorder for 12 weeks.	Atomoxetine n=35 participants at risk 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.
Psychiatric disorders difficulty concentrating	45.7% 16/35 • Number of events 16	65.7% 23/35 • Number of events 23

Additional Information

Christian Thurstone, M.D.

Denver Health

Phone: 303-436-6006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place