Treatment of Adult ADHD in Methadone Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Cocaine use based on urine toxicology
研究概览
简要总结
The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD) in methadone patients.
详细描述
This project is a three armed double-blind, placebo-controlled, randomized trial comparing the efficacy of MPH and BPR, relative to each other and to placebo, for treating persistent ADHD in methadone-maintained patients. One hundred and twenty subjects, will be randomized to receive either MPH, BPR, or placebo with equal probability. Randomization will be stratified by site, and whether or not cocaine is also being used. Efficacy will be measured by treatment retention, reduction in illicit drug use and drug craving, improvement of ADHD symptoms and overall functional status.
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
- 否
入选标准
- •Individuals who meet DSM-IV criteria for opiate dependence and are currently maintained on methadone
- •Patients must meet DSM-IV criteria for persistent adult ADHD
- •Must be on stable methadone dose for at least 3 weeks
- •Individuals positive for HIV will not be excluded.
排除标准
- •Patients meeting DSM-IV criteria for current psychiatric disorders (other than ADHD or substance abuse) which requires psychiatric intervention
- •Patients who are physiologically dependent on either sedatives or alcohol such that they experience symptoms requiring medical attention during periods of abstinence or significant reduction in amount of use
- •Individuals diagnosed with other forms of adult ADHD other than persistent, particularly substance-induced ADHD
- •Those who have an unstable medical condition which might make participation hazardous, including but not restricted to: uncontrolled hypertension, (SBP >160, DBP>100, PULSE >110), uncontrolled liver disease, uncontrolled diabetes, acute hepatitis, uncontrolled heart disease as indicated by history or abnormal ECG, glaucoma, or history of urinary retention or seizures, or advanced AIDS will not be included
- •Patients who are taking prescription psychotropic medications other than methadone
- •Patients who have exhibited suicidal or homicidal behavior within the past two years
- •Patients with known sensitivity to MPH or BPR
- •Patients with cognitive impairment or who cannot read or understand the self-report assessment forms unaided or are so severely disabled they cannot comply with the requirements of the study.
- •Patients unable to give full and informed consent
- •Patients with a history of an eating disorder
- •Patients recently convicted of a violent crime. (last two years)
- •Nursing mothers and pregnant women
研究组 & 干预措施
METHYLPHENIDATE
Methylphenidate
干预措施: Methylphenidate (Drug)
BUPROPION
Bupropion
干预措施: Bupropion (Drug)
PLACEBO
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Cocaine use based on urine toxicology
时间窗: collected 3 times per week for 12 weeks of the trial or length of study participation
ADHD symptom severity based on the ADHD Rating scale score
时间窗: measured once per week for 12 weeks or length of study participation
次要结局
未报告次要终点
研究者
Frances R Levin
Director of Substance Use Disorder
New York State Psychiatric Institute