Methylphenidate Treatment for Cocaine Abuse and ADHD - 1

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Methylphenidate Treatment for Cocaine Abuse and ADHD

Conditions
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Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders

Intervention / Treatment
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* Drug: Methylphenidate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>methylphenidate | Drug: Methylphenidate<br> <br> |
| Placebo Comparator: 2<br>placebo | Other: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD symptom severity based on the ADHD rating scale score |  | measured weekly for the 14 weeks of the trial or length of study participation | 
| self reported cocaine use |  | recorded daily for the 14 weeks of the trial or the length of participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Cocaine dependence, treatment, methylphenidate