Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Addiction severity
研究概览
简要总结
The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
详细描述
This 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. All subjects will receive methadone. For the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. Follow up evaluations will be conducted out to 3 months post treatment. Subjects will be assisted in transferring to Houston area methadone clinics to maintain treatment for opiate dependence following treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must:
- •Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID.
- •Be between 18 and 45 years old
- •Women must agree to use contraception
- •Have an EKG that has been confirmed by a cardiologist
- •Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal
排除标准
- •Subject must not:
- •Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent
- •Have any Axis I disorder that is not related to drug use
- •Have current dependence on any psychoactive disorder other than nicotine
- •Be on probation or parole for reasons other than those related to drug charges (ASI)
- •Be pregnant or lactating
- •Have been in any outside treatment in 3 months
结局指标
主要结局
Addiction severity
Craving
Medication compliance
Retention
Mood indicators
Psychiatric interview
Drug use
次要结局
- Effectiveness measures including psycho-social variables, side effects, and self-reported measures.