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

This study has been withdrawn prior to enrollment.
(Poor enrollment)
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01207622
First received: September 22, 2010
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Substance Use Disorder (SUD). The secondary objective of the study is to determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing SUD relapse.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Substance Use Disorder
 Drug: Atomoxetine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Enrollment: 0
Arms Assigned Interventions
Active Comparator: Atomoxetine Drug: Atomoxetine
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207622

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Timothy Wilens, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01207622     History of Changes
Other Study ID Numbers: 2003-P-001823, 5K24DA016264-02
Study First Received: September 22, 2010
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013