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OpenTrials
Completed

NCT Number: NCT01270555

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Chemically-Induced Disorders Mental Disorders Neurodevelopmental Disorders Substance Use Disorder (SUD) Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupropion SR

Drug

100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum

Other names: Wellbutrin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders

Important dates

Study start
1999
Primary completion
2001
First posted
Jan 5, 2011
Registry last updated
Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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