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

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Substance Use Disorder (SUD)
• Interventions: Drug: Bupropion SR

• Registration Number: NCT01270555
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-05
• Primary Completion: 2001-07
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-05
• Results First Submitted: 2011-01-07
• Results First Submitted QC: 2011-01-31
• Results First Posted: 2011-02-25
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bupropion	Bupropion SR	-

Primary Outcome Measures

Name	Time	Method
Self-reported Weekly Substance Use	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.
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score	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)

Secondary Outcome Measures

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