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

NCT01270555 | Completed Results

• 1 other identifier: 1999-P-009198
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity

  baseline and six weeks

• Clinical Global Impressions (CGI) Scale of ADHD Severity

  baseline and six weeks

• Hamilton Anxiety Scale (HAM-A)

  baseline and six weeks

• Hamilton Depression Scale (HAM-D)

  baseline and six weeks

• Beck Depression Inventory (BDI)

  baseline and six weeks

Study Arms (1)

Bupropion

EXPERIMENTAL

Drug: Bupropion SR

Interventions

Bupropion SR DRUG

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

Also known as: Wellbutrin

Bupropion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Substance-Related Disorders

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Timothy Wilens, MD
• Organization: Massachusetts General Hospital

twilens@partners.org

617-503-1053

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 5, 2011
• Study Start: May 1, 1999
• Primary Completion: July 1, 2001
• Last Updated: March 8, 2013
• Results First Posted: February 25, 2011

Record last verified: 2013-03