Back to resultsMethylphenidate in the Treatment of Cocaine Dependent Patients With Adult Attention Deficit Hyperactivity Disorder - 5
Primary Purpose
Cocaine-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility Criteria
Inclusion Criteria: Cocaine-dependent. Meets the DSM-IV criteria for ADHD. Actively using cocaine within the past 30 days of screening. Exclusion Criteria: Symptoms of AIDS. Significant medical disorder. DSM-IV criteria for any substance other than cocaine, alcohol, nicotine, marijuana, caffeine. Requires detoxification from ETOH or benzos. History of seizures.
Sites / Locations
- Cincinnati MDRU
Outcomes
Primary Outcome Measures
Cocaine use
Methylphenidate retention
Safety assessments
Psychosocial counseling sessions
Secondary Outcome Measures
Full Information
NCT ID
NCT00015223
First Posted
April 18, 2001
Last Updated
January 13, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati MDRU
1. Study Identification
Unique Protocol Identification Number
NCT00015223
Brief Title
Methylphenidate in the Treatment of Cocaine Dependent Patients With Adult Attention Deficit Hyperactivity Disorder - 5
Official Title
Methyphendidate in the Treatment of Cocaine Dependent Patients With Adult ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 1997 (undefined)
Primary Completion Date
July 1999 (Actual)
Study Completion Date
August 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 the use of Methylphenidate in the treatment of cocaine dependence and Attention Deficit Hyperactivity Disorder (ADHD) comorbidity.
Detailed Description
The objective of this study is to determine the safety and efficacy of methylphenidate in a population of patients who are cocaine dependent and suffer from attention deficit hyperactivity disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Substance-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Primary Outcome Measure Information:
Title
Cocaine use
Title
Methylphenidate retention
Title
Safety assessments
Title
Psychosocial counseling sessions
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:
Cocaine-dependent. Meets the DSM-IV criteria for ADHD. Actively using cocaine within the past 30 days of screening.
Exclusion Criteria:
Symptoms of AIDS. Significant medical disorder. DSM-IV criteria for any substance other than cocaine, alcohol, nicotine, marijuana, caffeine. Requires detoxification from ETOH or benzos. History of seizures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene Somoza, M.D.
Organizational Affiliation
U of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati MDRU
City
Cincinnati
State/Province
Ohio
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Methylphenidate in the Treatment of Cocaine Dependent Patients With Adult Attention Deficit Hyperactivity Disorder - 5
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