We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

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.

Condition or disease Intervention/treatment
Attention Deficit Hyperactivity Disorder (ADHD) Substance Use Disorder (SUD) Drug: Bupropion SR

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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
Primary Completion Date : July 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
More Information

Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01270555     History of Changes
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:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Substance-Related Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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