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

NCT ID: NCT01270555

Last Updated: 2013-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bupropion

Group Type: EXPERIMENTAL

Bupropion SR

Intervention Type: DRUG

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

Interventions

Bupropion SR

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

Intervention Type: DRUG

Other Intervention Names

Wellbutrin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Timothy Wilens, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1999-P-009198

Identifier Type: -

Identifier Source: org_study_id

NCT01012024

Identifier Type: -

Identifier Source: nct_alias