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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01207622
Collaborator
National Institutes of Health (NIH) (NIH), National Institute on Drug Abuse (NIDA) (NIH)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

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 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 or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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)

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Atomoxetine

Drug: Atomoxetine
Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Timothy Wilens, MD, MD, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01207622
    Other Study ID Numbers:
    • 2003-P-001823
    • 5K24DA016264-02
    First Posted:
    Sep 23, 2010
    Last Update Posted:
    Mar 5, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Hyperkinesis
    Disease
    Substance-Related Disorders
    Attention Deficit Disorder with Hyperactivity
    Atomoxetine Hydrochloride

    Study Results

    No Results Posted as of Mar 5, 2013