Pharmacotherapy & CM for Opioid and Cocaine Dependence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Average Number of Positive Urine Tests
研究概览
简要总结
The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence.
To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.
详细描述
We hypothesize that the treatment group receiving the combination of modafinil + Contingency Management will have significantly lower cocaine use than the other treatment conditions. We also hypothesize that improvements in memory, impulse control, and attention will be a significant contributor to the treatment improvements investigated in Specific Aim #1.
Opioid and cocaine dependence are major problems among veteran and non-veterans and no effective pharmacotherapy exists for cocaine dependence. Methadone has not shown robust effectiveness in reducing cocaine abuse. Thus, new treatments are needed for the individuals who have developed cocaine dependence. This study is designed to test a new pharmacotherapy for cocaine dependence and is a placebo-controlled trial.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female opioid-dependent patients between the ages of 18-65 will be entered into the study. Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods during study participation.
- •Current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal, self-reported history of opioid dependence for consecutive 12 month period and a positive urine for opiates.
- •Subjects must fulfill DSM-IV criteria for opioid and cocaine dependence.
- •Subjects must have a history of cocaine use, with a reported street cocaine use of a minimum of 1/2 gram during the preceding 30 days. Additionally, laboratory confirmation of recent cocaine use (positive urine for cocaine) within 2 weeks prior to admission to the study is required.
- •Subjects must be treatment-seekers for opioid and cocaine use.
- •Exclusion criteria:
- •Current DSM-IV diagnosis of other drug or alcohol dependence (other than opiates, cocaine, or tobacco)
- •History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
- •History of severe renal, endocrine or hepatic diseases.
- •History of psychosis, schizophrenia, or bipolar type I.
- •History of seizure disorder.
- •Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
- •Liver function tests (SGOT,SGPT) greater than 3 times normal.
- •Current use of modafinil
- •Current suicidality
- •Pregnancy or breast-feeding;
- •Medical contraindication to treatment with study medication (e.g. for modafinil, history of heart disease, ischemic ECG changes, arrhythmia, hypertension).
- •Women of child-bearing potential must agree to use other means of birth control and to have a pregnancy test repeated at least once monthly.
- •Known allergy to modafinil or methadone.
排除标准
- 未提供
研究组 & 干预措施
Modafinil Plus Contingency Magagement
Modafinil from 200mg up to 400mg plus Contingency Management
干预措施: Modafinil (Drug)
Modafinil Plus Contingency Magagement
Modafinil from 200mg up to 400mg plus Contingency Management
干预措施: Contingency Management (Behavioral)
Modafinil Plus Contingency Magagement
Modafinil from 200mg up to 400mg plus Contingency Management
干预措施: Methadone (Drug)
Modafinil Plus Contingency Magagement
Modafinil from 200mg up to 400mg plus Contingency Management
干预措施: cognitive behavioral treatment (Behavioral)
Sugar Pill Plus Contingency Management
Placebo: sugar pill
干预措施: Sugar Pill (Drug)
Sugar Pill Plus Contingency Management
Placebo: sugar pill
干预措施: Contingency Management (Behavioral)
Sugar Pill Plus Contingency Management
Placebo: sugar pill
干预措施: Methadone (Drug)
Sugar Pill Plus Contingency Management
Placebo: sugar pill
干预措施: cognitive behavioral treatment (Behavioral)
Modafinil Plus Voucher Control
干预措施: Modafinil (Drug)
Modafinil Plus Voucher Control
干预措施: Methadone (Drug)
Modafinil Plus Voucher Control
干预措施: cognitive behavioral treatment (Behavioral)
Modafinil Plus Voucher Control
干预措施: Voucher Control (Behavioral)
Sugar Pill Plus Voucher Control
干预措施: Sugar Pill (Drug)
Sugar Pill Plus Voucher Control
干预措施: Methadone (Drug)
Sugar Pill Plus Voucher Control
干预措施: cognitive behavioral treatment (Behavioral)
Sugar Pill Plus Voucher Control
干预措施: Voucher Control (Behavioral)
结局指标
主要结局
Average Number of Positive Urine Tests
时间窗: up to 12 weeks.
thrice weekly urine tests
Average Maximum Days Abstinent
时间窗: up to 84 days
次要结局
- Average Number of Days Using a Substance Within Treatment(up to 90 days)