Opioid Maintenance: Optimum Stabilization and Withdrawal
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- drug use
研究概览
简要总结
Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals.
详细描述
Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.
This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current opiate dependence
- •Provides acceptable proof of identity
- •History of 5 or more years of regular heroin use or dependence
- •Reads and writes English
排除标准
- •Significant suicidal or homicidal ideation, intent, or plan
- •Current AXIS I psychotic, depressive, or anxiety disorder
- •Meets DSM-IV criteria for dependence on any drug other than nicotine
- •Impending legal complications or incarceration
- •On parole or probation that requires reports of drug use or research data
- •Currently receiving treatment for opiate dependence
- •Currently participating in a 12-step substance detoxification program
- •Medical condition that contraindicates administration of ORLAAM
- •Plans to leave Houston, Texas within the year following study entry
- •Pregnant or breastfeeding
- •History of heart problems, including heart arrhythmias
- •Requires psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics)
研究组 & 干预措施
2
LAAM MaxEffect to 48 mg Adjust to effect (+/-)
干预措施: Levoacetyl Methadol (Drug)
1
LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks
干预措施: Levoacetyl Methadol (Drug)
3
LAAM Fixed Dose up to 48 mg 48 mg
干预措施: Levoacetyl Methadol (Drug)
结局指标
主要结局
drug use
时间窗: herion use over 20 week period
次要结局
未报告次要终点