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Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD), Substance Use Disorder (SUD)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupropion SR
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female outpatients 18 years old or older, up to 60 years old.
  • Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
  • Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included)

Exclusion Criteria:

  • Any clinically unstable medical condition
  • Clinically significant abnormal baseline laboratory values
  • Mental retardation (I.Q. <75) or Organic brain disorders
  • Seizure disorder
  • Patients with a history or an eating disorder including anorexia or bulimia nervosa
  • Pregnant or nursing females
  • Patients with current bipolar disorder
  • Psychotic disorder of any type
  • Patients on psychotropics known to treat ADHD (i.e. stimulants, tricyclics)
  • Patients receiving psychotherapy known to treat ADHD (i.e. cognitive or cognitive/behavioral psychotherapy)
  • Patients demonstrating active withdrawal from substance abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bupropion

    Arm Description

    Outcomes

    Primary Outcome Measures

    Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
    Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)
    Self-reported Weekly Substance Use
    Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.

    Secondary Outcome Measures

    Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity
    CGI-S 1=not ill, 7=extremely ill
    Clinical Global Impressions (CGI) Scale of ADHD Severity
    Global Severity (CGI-S) 1=not ill, 7=extremely ill
    Hamilton Anxiety Scale (HAM-A)
    minimum score (least severe anxiety) = 0, maximum (most severe) = 56
    Hamilton Depression Scale (HAM-D)
    minimum score (least severe depression) = 0, maximum score (most severe) = 84
    Beck Depression Inventory (BDI)
    minimum score (least severe depression) = 0, maximum score (most severe) = 63

    Full Information

    First Posted
    January 3, 2011
    Last Updated
    March 4, 2013
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01270555
    Brief Title
    Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults
    Official Title
    Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1999 (undefined)
    Primary Completion Date
    July 2001 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Hyperactivity Disorder (ADHD), Substance Use Disorder (SUD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bupropion
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Bupropion SR
    Other Intervention Name(s)
    Wellbutrin
    Intervention Description
    100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum
    Primary Outcome Measure Information:
    Title
    Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
    Description
    Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)
    Time Frame
    baseline and six weeks
    Title
    Self-reported Weekly Substance Use
    Description
    Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.
    Time Frame
    baseline and six weeks
    Secondary Outcome Measure Information:
    Title
    Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity
    Description
    CGI-S 1=not ill, 7=extremely ill
    Time Frame
    baseline and six weeks
    Title
    Clinical Global Impressions (CGI) Scale of ADHD Severity
    Description
    Global Severity (CGI-S) 1=not ill, 7=extremely ill
    Time Frame
    baseline and six weeks
    Title
    Hamilton Anxiety Scale (HAM-A)
    Description
    minimum score (least severe anxiety) = 0, maximum (most severe) = 56
    Time Frame
    baseline and six weeks
    Title
    Hamilton Depression Scale (HAM-D)
    Description
    minimum score (least severe depression) = 0, maximum score (most severe) = 84
    Time Frame
    baseline and six weeks
    Title
    Beck Depression Inventory (BDI)
    Description
    minimum score (least severe depression) = 0, maximum score (most severe) = 63
    Time Frame
    baseline and six weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female outpatients 18 years old or older, up to 60 years old. Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview. Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included) Exclusion Criteria: Any clinically unstable medical condition Clinically significant abnormal baseline laboratory values Mental retardation (I.Q. <75) or Organic brain disorders Seizure disorder Patients with a history or an eating disorder including anorexia or bulimia nervosa Pregnant or nursing females Patients with current bipolar disorder Psychotic disorder of any type Patients on psychotropics known to treat ADHD (i.e. stimulants, tricyclics) Patients receiving psychotherapy known to treat ADHD (i.e. cognitive or cognitive/behavioral psychotherapy) Patients demonstrating active withdrawal from substance abuse

    12. IPD Sharing Statement

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    Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults

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