NCT01779973已完成不适用
Remote Observed Dosing to Increase Suboxone Compliance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study.
研究概览
简要总结
The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate dependence. To that end, 10 opiate dependent subjects will be recruited through the University of Pennsylvania's Treatment Research Center, an outpatient substance abuse treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted as needed according to individual requirements).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Voluntarily provide written informed consent prior to the conduct of any study-related procedure
- •Male or female, 18 to 65 years of age,
- •Meet DSM-IV criteria for current opioid dependence
- •Females of childbearing potential and fertile males must use a reliable means of contraception
- •Owns a smartphone with forward facing camera that allows for use of Skype
排除标准
- •University of Pennsylvania student, employee, or affiliate
- •Current diagnosis of AIDS
- •Presence of AST and/or ALT equal to or 3X upper limit of normal
- •Total bilirubin and/or creatinine equal to or 1.5X upper limit or normal
- •Current diagnosis of chronic pain requiring opioids
- •Pregnant or lactating females
- •Previous hypersensitivity or allergy to buprenorphine or EVA-containing substances
- •Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and protease inhibitors (e.g. ritonavir, indinavir, saquinavir)
- •Meet DSM-IV criteria for current dependence on any psychoactive substances other than opioids or nicotine (e.g. alcohol, sedatives)
- •Current use of benzodiazepines other than physician prescribed
- •Significant medical or psychiatric symptoms or dementia which in the opinion of the investigators would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent
- •Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in the study; and/or any pending legal action that could prohibit participation and/or compliance in study procedures
- •Participated in a clinical study within the previous 8 weeks
结局指标
主要结局
The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study.
时间窗: 9 months
次要结局
- Patterns of missed doses including visit times and frequency impact.(9 months)
研究者
研究点 (2)
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