NCT00695864已完成不适用
Effect of Ondansetron for Withdrawal Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Withdrawal Symptoms With Placebo and With Ondansetron
研究概览
简要总结
We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •No medical contraindications to medication
- •Able to fulfill research procedures
排除标准
- •Subjects who are unable to respond to our questionnaires or to stimuli as required by the experimental protocol will be excluded.
- •Subjects will be excluded if they have a history of significant psychiatric disorders that would prevent them from engaging in a treatment program.
- •Participating in other studies that would interfere with the procedures in this study
- •Known or apparent pregnancy
研究组 & 干预措施
Placebo - sugar pill
Placebo Comparator
Placebo - sugar pill
干预措施: Ondansetron and Placebo crossover (Drug)
Ondansetron
Experimental
Ondansetron
干预措施: Ondansetron and Placebo crossover (Drug)
结局指标
主要结局
Change in Withdrawal Symptoms With Placebo and With Ondansetron
时间窗: Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron
Subjective Opioid Withdrawal Scale: Participants were asked to rate, from 0 to 4, their experience of 15 withdrawal symptoms. Scores for each participant were derived from the sum of their withdrawal symptoms score (minimum:0, maximum: 60). A higher score indicates more symptoms experienced and/or at a greater degree of severity.
次要结局
未报告次要终点
研究者
Sean Mackey
Principle Investigator
Stanford University
研究点 (1)
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