NCT00015054

Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3

MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the feasibility of methylphenidate (MPD) as effective and safe in the outpatient treatment of cocaine-dependent patients with a comorbid DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), to demonstrate the ability of each site to participate in a subsequent anticipated controlled trial of MPD (recruitment and execution), and to gather preliminary data on the ability of sweat patches to detect episodes of cocaine use.

Detailed description

Forty-one participants were enrolled into this multi-site, outpatient, open-label, ten-week trial. Participants were scheduled to attend three visits per week to allow safety and efficacy measures to be taken. In addition, participants were given two hours of individual substance abuse therapy during the first four weeks, and one hour per week during the last six weeks, of the trial. All participants were started on a total daily dose of 20 mg MPD. The total daily dose was then increased to a maximum daily dose of 60 mg (20 mg TID) or to the maximum dose tolerated by the participant.

Conditions

• Cocaine-Related Disorders

Interventions

Type	Name	Description
DRUG	Methylphenidate

Timeline

• Start date: 1998-09-01
• Primary completion: 1999-10-01
• Completion: 1999-11-01
• First posted: 2001-04-18
• Last updated: 2017-01-16

Locations

1 site across 1 country: United States