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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01207622
• Other study ID #: 2003-P-001823
• Secondary ID: 5K24DA016264-02
• Status: Withdrawn
• Phase: Phase 4
• First received: September 22, 2010
• Last updated: March 4, 2013

Study information

• Verified date: March 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis
• Substance Use Disorder
• Substance-Related Disorders

Intervention

Drug:
• Atomoxetine

• Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States,