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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Substance Use Disorder (SUD)
• Intervention / Treatment: Drug: Bupropion SR

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupropion	Drug: Bupropion SR; 100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum; Other Names: Wellbutrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 1999
• Primary Completion (Actual): July 1, 2001

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Estimate): March 8, 2013
• Last Update Submitted That Met QC Criteria: March 4, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Substance-Related Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: 1999-P-009198