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

Study Overview
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Brief Summary
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD), Substance Use Disorder (SUD)

Intervention / Treatment
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* Drug: Bupropion SR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion<br> | Drug: Bupropion SR<br>* 100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum<br>* Other names: Wellbutrin;|

What is the study measuring?
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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 |