Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015054
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2001-04-18
Brief Title:
Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients
Status:
COMPLETED
Status Verified Date:
1999-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Y01-5-0012-3 | None | None | None |