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Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD

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University of Pittsburgh

Status and phase

Completed
Phase 2

Conditions

Attention Deficit Hyperactivity Disorder
Substance Use Disorders

Treatments

Drug: Atomoxetine

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00029614
NIAAABUK00301
K24AA000301 (U.S. NIH Grant/Contract)
NIH Grant 5K24AA000301-05

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).

Enrollment

24 estimated patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adolescents, ages 13-18
  • Meets criteria for alcohol and/or substance use disorder and attention deficit hyperactivity disorder.

Exclusion criteria

  • Adolescents who are pregnant.
  • Have a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk.
  • History of pervasive development disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders.
  • Currently on other psychotropic medications from which discontinuation would present a significant risk.
  • A current episode of major depressive disorder or a diagnosis of bipolar disorder.
  • Diagnosis of dependence for any substance other than marijuana.
  • Adolescents with a full-scale IQ below 80.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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