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

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ClinicalTrials.gov Identifier: NCT00015223
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Cincinnati MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Substance-Related Disorders Drug: Methylphenidate Phase 2

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  (Clinical Trial)
Estimated Enrollment : 0 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Methyphendidate in the Treatment of Cocaine Dependent Patients With Adult ADHD
Study Start Date : June 1997
Primary Completion Date : July 1999
Study Completion Date : August 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Cocaine use
  2. Methylphenidate retention
  3. Safety assessments
  4. Psychosocial counseling sessions


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015223


Locations
United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Cincinnati MDRU
Investigators
Principal Investigator: Gene Somoza, M.D. U of Cincinnati

ClinicalTrials.gov Identifier: NCT00015223     History of Changes
Other Study ID Numbers: NIDA-5-0013-5
Y01-5-0013-5
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: October 2012

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Cocaine-Related Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Chemically-Induced Disorders
Methylphenidate
Cocaine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents