Back to resultsEfficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD
Primary Purpose
Attention Deficit Hyperactivity Disorder, Substance Use Disorder
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Atomoxetine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01207622
First Posted
September 22, 2010
Last Updated
March 4, 2013
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01207622
Brief Title
Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD
Official Title
Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Poor enrollment
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Substance Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atomoxetine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Intervention Type
Drug
Intervention Name(s)
Placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Wilens, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD
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