NCT00768482终止3 期
A Single Cross-Over, Open-Label Study of the Relative Bioavailability of Probuphine Versus Buprenorphine Sublingual Tablets at Steady State in Patients With Opioid Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Plasma BPN AUC(0-24)during 24 hours at steady state.
研究概览
简要总结
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
详细描述
This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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 procedures
- •Male or female, 18-75 years of age
- •Meet the DSM-IV criteria for current opioid dependence
- •Females of childbearing potential and fertile males must use a reliable means of contraception
排除标准
- •Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
- •Received treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
- •Current diagnosis of chronic pain requiring opioids for treatment
- •Candidates for only short term opioid treatment or opioid detoxification therapy
- •Pregnant or lactating females
- •Previous hypersensitivity or allergy to BPN or EVA-containing substances or naloxone
- •Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
- •Current history of coagulopathy, and/or anti-coagulant therapy (such as warfarin)
- •Meet the DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
- •Current use of benzodiazepines other than physician prescribed use
- •Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigators would preclude compliance with the protocol, patient safety, 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 study; and/or any pending legal action that could prohibit participation and/or compliance in study
- •Participated in a clinical study within the previous 8 weeks
- •Previous participation in a Probuphine clinical trial
- •Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels greater than or equal to 3 X upper limit of normal and/or total bilirubin greater than or equal to 1.5 X upper limit of normal and/or creatinine greater than or equal to 1.5 X upper limit of normal
- •Clinically significant low platelet count with current history of coagulopathy
研究组 & 干预措施
Probuphine
Experimental
Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants
干预措施: Probuphine (buprenorphine implant) (Drug)
Probuphine
Experimental
Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants
干预措施: Sublingual Buprenorphine (Drug)
结局指标
主要结局
Plasma BPN AUC(0-24)during 24 hours at steady state.
时间窗: Day -1, Day -2 and Week 4
次要结局
- Plasma BPN and NorBPN Cmax(week 4)
- Time to maximum plasma BPN and NorBPN concentration (tmax)(Day -2, Day -1 and Day 1)
- Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state(week 4)
- Change in plasma BPN concentration(24 weeks)
- Number of subjects with adverse events as a measure of safety and tolerability(approx. 11 weeks (due to study termination))
研究者
研究点 (1)
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