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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01270555

Enrollment

Registered

2011-01-05

Start date

1999-05-31

Completion date

Unknown

Last updated

2013-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGBupropion SR

100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)
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.

Secondary

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

Participant flow

Participants by arm

Arm	Count
Bupropion Once daily treatment with Bupropion with intention to treat ADHD and SUD.	32
Total	32

Baseline characteristics

Characteristic	Bupropion
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	32 Participants
Age Continuous	32 years STANDARD_DEVIATION 8.5
Beck Depression Inventory (BDI)	8.9 Units on a scale STANDARD_DEVIATION 5.9
Clinical Global Impressions (CGI) Score for ADHD Severity	5.0 Units on a scale STANDARD_DEVIATION 0.7
Clinical Global Impressions (CGI) Score for SUD Severity	4.0 Units on a scale STANDARD_DEVIATION 0.9
DSM-IV Attention Deficit Hyperactivity Rating Scale (ADHD RS)	34.1 Units on a scale STANDARD_DEVIATION 8.2
Hamilton Anxiety Rating Scale (HAM-A)	8.1 Units on a scale STANDARD_DEVIATION 6.5
Hamilton Depression rating Scale (HAM-D)	8.8 Units on a scale STANDARD_DEVIATION 9.1
Region of Enrollment United States	32 participants
Self-reported Weekly substance use	32 Participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	26 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 32
serious Total, serious adverse events	0 / 32

Outcome results

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)