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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00015223
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 16, 2017
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)
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
Actual Primary Completion Date : July 1999
Actual 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00015223

United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Cincinnati MDRU
Principal Investigator: Gene Somoza, M.D. U of Cincinnati Identifier: NCT00015223     History of Changes
Other Study ID Numbers: NIDA-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:
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
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
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents