Efficacy of Bupropion for ADHD in Adults

To evaluate the effectiveness and tolerability of bupropion in adults with Attention-Deficit/Hyperactivity Disorder (ADHD) and co-occurring active Substance Use Disorders (SUD)...

Date First Received: November 9, 2009

Last Updated: November 9, 2009

Verified by: National Institute on Drug Abuse (NIDA), November 2009

Clinical Trial Phase: Phase 4 | Start Date: January 1999

Overall Status: Completed

Estimated Enrollment: 32

Brief Summary

Official Title: “An Open Trial of Sustained Bupropion for Attention-Deficit/Hyperactivity Disorder in Adults With ADHD Plus Substance Use Disorders”

To evaluate the effectiveness and tolerability of bupropion in adults with Attention-Deficit/Hyperactivity Disorder (ADHD) and co-occurring active Substance Use Disorders (SUD).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2001

Detailed Clinical Trial Description

Objective: To evaluate the effectiveness and tolerability of bupropion in adults with Attention-Deficit/Hyperactivity Disorder (ADHD) and comorbid active Substance Use Disorders (SUD). Methods: This was a six-week open trial of sustained-release (SR) bupropion in adults aged 18 to 55 years diagnosed with both ADHD and SUD. Bupropion-SR was initiated at 100 mg SR and increased weekly to a target dose of 200 mg SR twice daily. Subjects were assessed on multiple outcomes including ADHD, SUD, and adverse effects. All analyses were intent to treat, with last observation carried forward. Results: Thirty-two subjects were treated with bupropion, with nineteen subjects completing the entire protocol (59%). At end point there were clinically significant reductions in the ADHD RS (34.1±8.2 to 19.4±11.4, -43%, t=6.49, p<0.0001) and the Clinical Global Impression (CGI) of ADHD severity (baseline=5.0, endpoint=3.8, -24%, t=6.16, p<0.0001). In contrast, there were clinically negligible effects on the self-report of substance use (p's >0.05) and on the overall CGI of SUD severity (-23%, t=4.95, p<0.0001). Conclusions: Results from this open trial suggest that in adults with ADHD and SUD, treatment with bupropion-SR is associated with clinically significant reductions in ADHD, but not SUD.

Intervention(s) in this Clinical Trial

  • Drug: Bupropion Sustained Release (SR)
    • Study medication was begun at 100 mg SR in the morning and increased by 100 mg SR weekly in twice a day dosing up to 200 mg SR twice daily (week 4).

Outcome Measures for this Clinical Trial

Primary Measures

  • ADHD Rating Scale
    • Time Frame: Weekly
      Safety Issue?: No
  • Self Reported Substance Use Questionnaire
    • Time Frame: Weekly
      Safety Issue?: No

Secondary Measures

  • Hamilton Depression Scale
    • Time Frame: Baseline and Endpoint
      Safety Issue?: No
  • Hamilton Anxiety Scale
    • Time Frame: Baseline and Endpoint
      Safety Issue?: No
  • Beck Depression Inventory
    • Time Frame: Baseline and Endpoint
      Safety Issue?: No
  • Clinical Global Impression Severity Scale for ADHD
    • Time Frame: Weekly
      Safety Issue?: No
  • Clinical Global Impression Improvement Scale for ADHD
    • Time Frame: Weekly
      Safety Issue?: No
  • Clinical Global Impression Severity Scale for Substance Use
    • Time Frame: Weekly
      Safety Issue?: No
  • Clinical Global Impression Improvement Scale for Substance Use
    • Time Frame: Weekly
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Subjects were outpatient men and women between 18 and 55 years of age who were recruited from advertisements and clinical referrals to a psychopharmacology outpatient clinic seeking treatment for ADHD. In addition to having ADHD these subjects were identified as having active non-nicotine SUD. Patients treated with naltrexone for decreasing alcohol cravings, methadone as opioid replacement, and nicotine patch or gum as tobacco replacement were admitted into the study.

Exclusion Criteria:

  • (1) clinically significant and unstable medical conditions, history of cardiac arrhythmias, eating disorders, seizure disorder, or hypertension; (2) clinically significant abnormal ECG; (3) pregnant or nursing females; (4) mental retardation (I.Q. <75); (5) organic brain disorders; (6) clinically unstable psychiatric conditions, including patients with active suicidal ideation, lifetime bipolar or psychotic disorders; (7) an unstable substance use disorder (i.e., demonstrating active withdrawal from substances meriting medical treatment, recent intravenous use, unable to utilize either public transportation to/from hospital or to ensure safety while driving); or (8) current use of psychotropic medication known to treat ADHD.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Timothy E Wilens, M.D. Principal Investigator Massachusetts General Hospital  

Related Publications

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Additional Information

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01012024

Study ID Number: 1999-P-009198

ClinicalTrials.gov Identifier: NCT01012024

Health Authority: United States: Federal Government

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