Methylphenidate in the Treatment of Cocaine Dependent Patients With Adult Attention Deficit Hyperactivity Disorder - 5

January 13, 2017 updated by: National Institute on Drug Abuse (NIDA)

Methyphendidate in the Treatment of Cocaine Dependent Patients With Adult ADHD

The purpose of this study is the use of Methylphenidate in the treatment of cocaine dependence and Attention Deficit Hyperactivity Disorder (ADHD) comorbidity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States
        • Cincinnati MDRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cocaine use
Safety assessments
Methylphenidate retention
Psychosocial counseling sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Cincinnati MDRU

Investigators

  • Principal Investigator: Gene Somoza, M.D., U of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1997

Primary Completion (ACTUAL)

July 1, 1999

Study Completion (ACTUAL)

August 1, 1999

Study Registration Dates

First Submitted

April 18, 2001

First Submitted That Met QC Criteria

April 17, 2001

First Posted (ESTIMATE)

April 18, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-5-0013-5
  • Y01-5-0013-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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