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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Cincinnati MDRU |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00015054 |
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.
Condition | Intervention | Phase |
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Cocaine-Related Disorders |
Drug: Methylphenidate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients |
Estimated Enrollment: | 20 |
Study Start Date: | September 1998 |
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.
Ages Eligible for Study: | 21 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NIDA-5-0012-3, Y01-5-0012-3 |
Study First Received: | April 18, 2001 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00015054 |
Health Authority: | United States: Federal Government |
Cocaine-Related Disorders Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Substance-Related Disorders |
Methylphenidate Attention Deficit and Disruptive Behavior Disorders Disorders of Environmental Origin Hyperkinesis Cocaine |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |