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

This study has been completed.

First Received on April 18, 2001. Last Updated on August 25, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	New York MDRU
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00015223

Purpose

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

Condition	Intervention	Phase
Cocaine-Related Disorders Substance-Related Disorders	Drug: Methylphenidate	Phase II

Study Type:	Interventional
Study Design:	Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Methyphendidate in the Treatment of Cocaine Dependent Patients With Adult ADHD

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Drug Abuse

Drug Information available for: Cocaine hydrochloride Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Cocaine use
Methylphenidate retention
Safety assessments
Psychosocial counseling sessions

Estimated Enrollment:	0
Study Start Date:	June 1997

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.

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015223

Locations

United States, New York
New York MDRU
New York, New York, United States, 10010

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

New York MDRU

Investigators

Principal Investigator:

John Rotrosen, M.D.

New York MDRU

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00015223 History of Changes
Other Study ID Numbers:	NIDA-5-0013-5, Y01-5-0013-5
Study First Received:	April 18, 2001
Last Updated:	August 25, 2008
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine-Related Disorders
Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012