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

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ClinicalTrials.gov Identifier: NCT01270555
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : February 25, 2011
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Substance Use Disorder (SUD) Drug: Bupropion SR Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders
Study Start Date : May 1999
Actual Primary Completion Date : July 2001

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Bupropion Drug: Bupropion SR
100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum
Other Name: Wellbutrin


Outcome Measures
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Primary Outcome Measures :
  1. Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score [ Time Frame: baseline and six weeks ]
    Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)

  2. Self-reported Weekly Substance Use [ Time Frame: baseline and six weeks ]
    Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.


Secondary Outcome Measures :
  1. Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity [ Time Frame: baseline and six weeks ]
    CGI-S 1=not ill, 7=extremely ill

  2. Clinical Global Impressions (CGI) Scale of ADHD Severity [ Time Frame: baseline and six weeks ]
    Global Severity (CGI-S) 1=not ill, 7=extremely ill

  3. Hamilton Anxiety Scale (HAM-A) [ Time Frame: baseline and six weeks ]
    minimum score (least severe anxiety) = 0, maximum (most severe) = 56

  4. Hamilton Depression Scale (HAM-D) [ Time Frame: baseline and six weeks ]
    minimum score (least severe depression) = 0, maximum score (most severe) = 84

  5. Beck Depression Inventory (BDI) [ Time Frame: baseline and six weeks ]
    minimum score (least severe depression) = 0, maximum score (most severe) = 63


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01270555    
Obsolete Identifiers: NCT01012024
Other Study ID Numbers: 1999-P-009198
First Posted: January 5, 2011    Key Record Dates
Results First Posted: February 25, 2011
Last Update Posted: March 8, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Chemically-Induced Disorders
Bupropion
 Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors