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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion SR | Drug | 100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupropion | Once daily treatment with Bupropion with intention to treat ADHD and SUD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupropion | Once daily treatment with Bupropion with intention to treat ADHD and SUD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | Units on a scale | baseline and six weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupropion | Once daily treatment with Bupropion with intention to treat ADHD and SUD. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Wilens, MD | Massachusetts General Hospital | 617-503-1053 | twilens@partners.org |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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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 |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| DSM-IV Attention Deficit Hyperactivity Rating Scale (ADHD RS) | Assesses 18 individual criteria symptoms on a severity grid (0=not present, 3=severe; overall minimum score = 0, maximum score = 54) | Mean | Standard Deviation | Units on a scale |
|
| Self-reported Weekly substance use | Participants who self-report using at least one of illegal drugs or alcohol, at least once per week. | Number | Participants |
|
| Clinical Global Impressions (CGI) Score for SUD Severity | Global Severity 1=not ill, 7=extremely ill | Mean | Standard Deviation | Units on a scale |
|
| Clinical Global Impressions (CGI) Score for ADHD Severity | Global Severity 1=not ill, 7=extremely ill | Mean | Standard Deviation | Units on a scale |
|
| Hamilton Anxiety Rating Scale (HAM-A) | minimum (least severe anxiety) = 0, maximum (most severe) = 56 | Mean | Standard Deviation | Units on a scale |
|
| Hamilton Depression rating Scale (HAM-D) | minimum (least severe depression) = 0, maximum (most severe) = 84 | Mean | Standard Deviation | Units on a scale |
|
| Beck Depression Inventory (BDI) | minimum (least severe depression) = 0, maximum (most severe) = 63 | Mean | Standard Deviation | Units on a scale |
|
|
| Secondary | Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity | CGI-S 1=not ill, 7=extremely ill | Posted | Mean | Standard Deviation | Units on a scale | baseline and six weeks |
|
|
|
| Secondary | Clinical Global Impressions (CGI) Scale of ADHD Severity | Global Severity (CGI-S) 1=not ill, 7=extremely ill | Posted | Mean | Standard Deviation | Units on a scale | baseline and six weeks |
|
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|
| 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. | Posted | Number | Participants | baseline and six weeks |
|
|
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| Secondary | Hamilton Anxiety Scale (HAM-A) | minimum score (least severe anxiety) = 0, maximum (most severe) = 56 | Posted | Mean | Standard Deviation | Units on a scale | baseline and six weeks |
|
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| Secondary | Hamilton Depression Scale (HAM-D) | minimum score (least severe depression) = 0, maximum score (most severe) = 84 | Posted | Mean | Standard Deviation | Units on a scale | baseline and six weeks |
|
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|
| Secondary | Beck Depression Inventory (BDI) | minimum score (least severe depression) = 0, maximum score (most severe) = 63 | Posted | Mean | Standard Deviation | Units on a scale | baseline and six weeks |
|
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| 0 |
| 32 |
| 0 |
| 32 |
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