NCT01114308已完成3 期
A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine 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
- 已完成
- 入组人数
- 287
- 试验地点
- 20
- 主要终点
- CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24
研究概览
简要总结
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 procedures
- •Male or female, 18-65 years of age
- •Meet DSM-IV-TR criteria for current opioid dependence
- •Females of childbearing potential or a fertile male, must use a reliable means of contraception
排除标准
- •Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
- •Received any medication-assisted treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
- •Current diagnosis of chronic pain requiring opioids for treatment
- •Candidates for short-term opioid treatment (<6 months) only, or opioid detoxification therapy
- •Pregnant or lactating female?
- •Previous hypersensitivity or allergy to BPN, 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), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
- •History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
- •Meet the DSM-IV-TR criteria for dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
- •Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent
- •Current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study
- •Exposure to any investigational drug within the previous 8 weeks
- •Previous exposure to Probuphine, or prior implantation with a placebo implant in the context of a Probuphine clinical trial
- •Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X the upper limit of normal, alanine aminotransferase (ALT) levels greater than or equal to 3 X the upper limit of normal, total bilirubin greater than or equal to 1.5 X the upper limit of normal, or creatinine greater than 1.5 X upper limit of normal on the screening laboratory assessments
- •Clinically significant low platelet count on the screening laboratory assessments
研究组 & 干预措施
Probuphine
Experimental
Patients are first inducted on SL BPN then switched to 4 buprenorphine implants
干预措施: Probuphine (buprenorphine implant) (Drug)
placebo implant
Placebo Comparator
patients are first inducted on SL BPN then switched to 4 placebo implants
干预措施: placebo implant (Drug)
sublingual buprenorphine
Active Comparator
patients are inducted on SL BPN, then continue on SL BPN
干预措施: Buprenorphine (Drug)
结局指标
主要结局
CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24
时间窗: 1-24 weeks
CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups
时间窗: 1-24 weeks
次要结局
- CDF of the percent of urine samples negative for opioids from weeks 17-24(17-24 weeks)
- CDF of the percent of urine samples negative for opioids from weeks 1-16(1-16 weeks)
- Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN(24 weeks)
研究者
研究点 (20)
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