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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270555
• Other study ID #: 1999-P-009198
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: March 4, 2013
• Start date: May 1999

Study information

• Verified date: March 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01012024

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Disease
• Hyperkinesis
• Substance Use Disorder (SUD)
• Substance-Related Disorders

Intervention

Drug:
• Bupropion SR
100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline and six weeks	No
Primary	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.	baseline and six weeks	No
Secondary	Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity	CGI-S 1=not ill, 7=extremely ill	baseline and six weeks	No
Secondary	Clinical Global Impressions (CGI) Scale of ADHD Severity	Global Severity (CGI-S) 1=not ill, 7=extremely ill	baseline and six weeks	No
Secondary	Hamilton Anxiety Scale (HAM-A)	minimum score (least severe anxiety) = 0, maximum (most severe) = 56	baseline and six weeks	No
Secondary	Hamilton Depression Scale (HAM-D)	minimum score (least severe depression) = 0, maximum score (most severe) = 84	baseline and six weeks	No
Secondary	Beck Depression Inventory (BDI)	minimum score (least severe depression) = 0, maximum score (most severe) = 63	baseline and six weeks	No