Methylphenidate Treatment for Cocaine Abuse and ADHD - 1
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.
Attention Deficit Disorder With Hyperactivity
|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 ]
|Study Start Date:||April 1998|
|Study Completion Date:||March 2004|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136734
|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.|