Combined Treatment for Cocaine-Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Urine toxicology for cocaine
研究概览
简要总结
The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy can be helpful in patients who want to stop using cocaine and alcohol.
详细描述
This is a randomized, double blind placebo-controlled trial to examine the role of Relapse Prevention (RP) and Contingency Management (CMP) combined with Naltrexone (NTX) for the treatment of cocaine-alcohol dependence. Patients will be randomly assigned to NTX (100mg/d) or placebo combined with one of two psychotherapy conditions (RP or RP +CMP). Following a standardized consent and intake procedure patients will participate in a 12-week trial with thrice weekly visits. Manual-guided RP therapy will be delivered in weekly 60-minute individual sessions. CMP will be based on cocaine-negative urine screens and negative breath alcohol tests. Follow-up assessments will be conducted at 3 and 6 months after treatment.
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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •Give informed consent
- •Be able to understand the nature of the study, agree to comply with study requirements, report regularly for scheduled visits, and communicate with study personnel about adverse events and concomitant medication use
- •Be between 18 and 60 years old
- •Meet DSM-IV criteria for both current cocaine and alcohol dependence
- •Be in acceptable health based on physical exam, lab tests, and EKG
- •Have a stable living situation and the availability of at least two locators
- •Be able to read and write English at the 6th grade level
- •Provide a least one cocaine positive urine during intake
- •If female, must agree to use contraception
排除标准
- •History of evidence of a medical condition that would expose them to an undue risk or interfere with assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, or neurologic disease as determined by the clinical judgment of the research team
- •Medical condition that is contraindicated with opioid antagonists or necessitates opiate medication
- •Abnormal liver function test results (both ALT and AST >3x upper limit normal or either >5x upper limit normal)
- •Currently in treatment or have received treatment in the past six months for substance abuse or another psychiatric condition
- •Evidence of a Axis I disorder that will interfere with the course of the trial, including but not limited to current Major Depressive Disorder, Bipolar Disorder, Panic Disorder, Schizophrenia, Bulimia nervosa or Anorexia, and Post-traumatic stress disorder as determined by the clinical judgment of the research team
- •Participating in 12 step meetings more than twice weekly
- •Opiate abuse or dependence in the last five years or used opiates, barbiturates, benzodiazepines in the last thirty days
- •Current dependence on any psychoactive disorder other than nicotine
- •Impending incarceration
- •Condition of probation or parole requiring reports of drug use to officers of the court
- •Women of child bearing potential must not be pregnant/lactating or unwilling to use an acceptable contraceptive method
- •Plans to move from the Houston area within the next three months
研究组 & 干预措施
1
Naltrexone
干预措施: Naltrexone (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Urine toxicology for cocaine
时间窗: 12 weeks of study
次要结局
未报告次要终点
研究者
Joy Schmitz
Professor - Psy, Behavioral Science
The University of Texas Health Science Center, Houston