NCT00000326撤回2 期
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Drug effect characteristics
研究概览
简要总结
The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
详细描述
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
排除标准
- •Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
结局指标
主要结局
Drug effect characteristics
Dose order estimate-nurse
Dose order estimate-client
Pupil diameter
Retention
Observed withdrawal rating
Opioid antagonist rating
Analog rating scale for drug effects
Drug use
Subjective dose estimate
Opioid agonist rating
Compliance
次要结局
未报告次要终点
研究者
研究点 (2)
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