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临床试验/NCT00136734
NCT00136734已完成1 期

Methylphenidate Treatment for Cocaine Abuse and ADHD

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 1998年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
124
试验地点
1
主要终点
ADHD symptom severity based on the ADHD rating scale score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

1

Experimental

methylphenidate

干预措施: Methylphenidate (Drug)

2

Placebo Comparator

placebo

干预措施: placebo (Other)

结局指标

主要结局

ADHD symptom severity based on the ADHD rating scale score

时间窗: measured weekly for the 14 weeks of the trial or length of study participation

self reported cocaine use

时间窗: recorded daily for the 14 weeks of the trial or the length of participation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frances R Levin

Director of Substance Use Disorder

New York State Psychiatric Institute

研究点 (1)

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