Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD

Status:

WITHDRAWN

Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

National Institutes of Health (NIH)

National Institute on Drug Abuse (NIDA)

Conditions:

Attention Deficit Hyperactivity Disorder

Substance Use Disorder

Eligibility:

All Genders

15-30 years

Phase:

PHASE4

Brief Summary

The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD) with comorbid Su...

Eligibility Criteria

Inclusion

Male and female outpatients 15-30 years.
Subjects with a DSM-IV diagnosis of ADHD (combined or inattentive subtype) as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
Subjects with a current or recent (within three months) substance use disorder (drugs or alcohol) as determined through clinical evaluation and/or ascertained through structured diagnostic interview.
Subjects with an ADHD CGI-S of \>= 4 (moderate impairment).

Exclusion

Pregnant or nursing females.
Subjects with a clinically unstable medical condition that will either jeopardize patient safety or affect the scientific merit of the study, or who undergo a change in treatment during the study.
Recent history of intravenous drug use, or subjects who have current DSM-IV criteria for abuse or dependence of cocaine, MDA, MDMA, gammahydroxybutyrate, methamphetamines, amphetamines, opioids, PCP, or benzodiazepines that in the opinion of the investigator will interfere in their ability to participate safely in the study.
Subjects with Mental Retardation or Organic Brain Syndromes.
Subjects who are psychotic or have a history of bipolar disorder.
Participants who are taking any psychotropic or anti-SUD medications will be excluded from the study.
Current DSM-IV diagnosis of major depression, depressive disorders, or anorexia as manifested by clinical interviews.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01207622

Last Update

March 5 2013

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