Methylphenidate Treatment for Cocaine Abuse and ADHD - 1
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders |
Drug: Methylphenidate Other: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Methylphenidate Treatment for Cocaine Abuse and ADHD |
- 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 ] [ Designated as safety issue: No ]
- self reported cocaine use [ Time Frame: recorded daily for the 14 weeks of the trial or the length of participation ] [ Designated as safety issue: No ]
| Enrollment: | 124 |
| Study Start Date: | April 1998 |
| Study Completion Date: | March 2004 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
methylphenidate
|
Drug: Methylphenidate |
|
Placebo Comparator: 2
placebo
|
Other: placebo
placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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| United States, New York | |
| Research Foundation for Mental Hygiene, Inc. | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Frances R Levin, M.D. | Research Foundation for Mental Hygiene, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00136734 History of Changes |
| Other Study ID Numbers: | #3236-NIDA-011755-1, R01DA011755, R01-DA011755-1, DPMC |
| Study First Received: | August 25, 2005 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Attention Deficit Disorder with Hyperactivity Hyperkinesis Substance-Related Disorders Mental Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
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 May 19, 2013