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Methylphenidate Treatment for Cocaine Abuse and ADHD - 1

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ClinicalTrials.gov Identifier: NCT00136734
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : April 7, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Many cocaine dependent individuals are also diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Methylphenidate (Ritalin) is currently approved to treat individuals diagnosed with ADHD. The purpose of this study is to determine the effectiveness of methylphenidate in treating ADHD symptoms in cocaine dependent individuals.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders Drug: Methylphenidate Other: placebo Phase 1

Detailed Description:

Methylphenidate (MPH) is commonly used to treat individuals diagnosed with ADHD. The purpose of this study is to determine the effectiveness of MPH in treating adult cocaine dependent individuals who are also diagnosed with ADHD.

Participants in this 14-week, double-blind, placebo-controlled study will be randomly assigned to receive either sustained-release MPH or placebo. All participants will receive individual cognitive behavioral therapy. The trial will last 14 weeks. It will include a 1-week placebo lead-in phase and a 2-week dose titration phase, followed by 11 weeks on a stable dose of MPH. During the titration phase, MPH will be given twice a day, starting at a dose of 10 mg/day. The dose will increase by 10 mg each day, until a final stable dose of 40 mg/day is reached. At this time, sustained-release MPH will be given as two 20 mg doses (one in the morning and one in the afternoon). Depending on a participant's tolerance of MPH, the dose will be increased to a maximum of 60 mg/day (40 mg in the morning and 20 mg in the afternoon). Participants who are unable to tolerate a dose of at least 40 mg/day of MPH will be discontinued from the study. Assessments of ADHD symptoms will be completed at weekly study visits. In addition, drug use assessments will also be completed and will include self-reports and urine toxicology tests.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methylphenidate Treatment for Cocaine Abuse and ADHD
Study Start Date : April 1998
Primary Completion Date : March 2004
Study Completion Date : March 2004

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Drug: Methylphenidate
Placebo Comparator: 2
Other: placebo

Outcome Measures

Primary Outcome Measures :
  1. ADHD symptom severity based on the ADHD rating scale score [ Time Frame: measured weekly for the 14 weeks of the trial or length of study participation ]
  2. self reported cocaine use [ Time Frame: recorded daily for the 14 weeks of the trial or the length of participation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets DSM-IV criteria for cocaine dependence
  • Meets DSM-IV criteria for persistent adult Attention Deficit Hyperactive Disorder

Exclusion Criteria:

  • Meets DSM-IV criteria for current psychiatric disorders (other than ADHD or substance abuse) that requires a psychiatric intervention
  • Physiologically dependent on sedatives or alcohol, to the extent that medical attention is required during periods of abstinence or significant reduction in the amount of use
  • Exhibits suicidal or homicidal behavior within the two years prior to enrollment
  • Currently taking prescription psychotropic medication
  • Unstable medical condition (e.g., uncontrolled diabetes) that would make participation in the study hazardous
  • Known sensitivity to methylphenidate
  • Pregnant or breastfeeding
Contacts and Locations

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): NCT00136734

United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Frances R Levin, M.D. Research Foundation for Mental Hygiene, Inc.
More Information

Additional Information:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00136734     History of Changes
Other Study ID Numbers: #3236-NIDA-011755-1
R01DA011755 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016

Keywords provided by New York State Psychiatric Institute:
Cocaine dependence

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Cocaine-Related Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Substance-Related 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