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

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject must be between 21 and 50 years of age, male or female, of any race. If female, subject cannot be pregnant or lactating. Subject must be cocaine-dependent (as determined by the SCID and a clinical interview by a psychiatrist). Subject must meet DSM-IV diagnostic criteria for ADHD: Subject must have been actively using cocaine, (BE>300 ng/ml) within 30 days of the screening examination. Subject must be negative for cocaine metabolites immediately prior to receiving a study treatment number and initial dose of MPD, as determined first by urine testing kit with result later confirmed by laboratory urine toxicology (BE < 300 ng/ml). Subject must be willing and able to give informed consent. Exclusion Criteria: Subject has symptoms of AIDS. Subject has a chronic medical disorder requiring medication. Subject has a SCID Axis-I psychiatric diagnosis requiring medication. Subject meets DSM-IV criteria for dependence for any substance except cocaine, alcohol, nicotine, marijuana, caffeine, and has been actively using during the past two weeks. Subject is in need of detoxification from alcohol or benzodiazepines Subject is taking psychotropic medication (except chloral hydrate for insomnia). Subject is female of childbearing age who is at risk for becoming pregnant and is not using adequate contraceptive techniques as determined by the evaluating physician or Principal Investigator. Subject has ALT or AST levels above three times laboratory normal Subject has renal function tests (creatinine and BUN) or electrolyte levels (K, Na, Cl, HCO3) that are not within normal limits at baseline. Subject has an EKG indicating clinically significant arrhythmias or abnormal conduction Subject has organic brain syndrome (OBS) as evidenced in the psychiatric evaluation. Subject has an acute or chronic medical or psychiatric condition which in the judgment of the evaluating physician would make study participation difficult or unsafe. Subject has been enrolled in another research protocol within the past 45 days. Subject has narrow angle glaucoma, by history Subject has a diagnosis or family history of Tourettes syndrome Subject has a history of seizures or seizure disorder Subject has had an adverse reaction to methylphenidate Subject has abnormal thyroid function (as determined by an abnormal T4 level that is clinically significant) Subject has been treated for ADHD with psychomotor stimulants within the past month. Subject plans to receive psychosocial treatment external to that designated in the protocol during study participation.

Sites / Locations

  • Cincinnati MDRU

Outcomes

Primary Outcome Measures

Retention
Cocaine use
Global improvement

Secondary Outcome Measures

Full Information

First Posted
April 18, 2001
Last Updated
January 13, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati MDRU
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1. Study Identification

Unique Protocol Identification Number
NCT00015054
Brief Title
Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3
Official Title
MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 1999
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
October 1999 (Actual)
Study Completion Date
November 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati MDRU

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Primary Outcome Measure Information:
Title
Retention
Title
Cocaine use
Title
Global improvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be between 21 and 50 years of age, male or female, of any race. If female, subject cannot be pregnant or lactating. Subject must be cocaine-dependent (as determined by the SCID and a clinical interview by a psychiatrist). Subject must meet DSM-IV diagnostic criteria for ADHD: Subject must have been actively using cocaine, (BE>300 ng/ml) within 30 days of the screening examination. Subject must be negative for cocaine metabolites immediately prior to receiving a study treatment number and initial dose of MPD, as determined first by urine testing kit with result later confirmed by laboratory urine toxicology (BE < 300 ng/ml). Subject must be willing and able to give informed consent. Exclusion Criteria: Subject has symptoms of AIDS. Subject has a chronic medical disorder requiring medication. Subject has a SCID Axis-I psychiatric diagnosis requiring medication. Subject meets DSM-IV criteria for dependence for any substance except cocaine, alcohol, nicotine, marijuana, caffeine, and has been actively using during the past two weeks. Subject is in need of detoxification from alcohol or benzodiazepines Subject is taking psychotropic medication (except chloral hydrate for insomnia). Subject is female of childbearing age who is at risk for becoming pregnant and is not using adequate contraceptive techniques as determined by the evaluating physician or Principal Investigator. Subject has ALT or AST levels above three times laboratory normal Subject has renal function tests (creatinine and BUN) or electrolyte levels (K, Na, Cl, HCO3) that are not within normal limits at baseline. Subject has an EKG indicating clinically significant arrhythmias or abnormal conduction Subject has organic brain syndrome (OBS) as evidenced in the psychiatric evaluation. Subject has an acute or chronic medical or psychiatric condition which in the judgment of the evaluating physician would make study participation difficult or unsafe. Subject has been enrolled in another research protocol within the past 45 days. Subject has narrow angle glaucoma, by history Subject has a diagnosis or family history of Tourettes syndrome Subject has a history of seizures or seizure disorder Subject has had an adverse reaction to methylphenidate Subject has abnormal thyroid function (as determined by an abnormal T4 level that is clinically significant) Subject has been treated for ADHD with psychomotor stimulants within the past month. Subject plans to receive psychosocial treatment external to that designated in the protocol during study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Somoza, M.D., Ph.D.
Organizational Affiliation
Cincinnati MDRU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati MDRU
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

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

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