A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 9
- 主要终点
- Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of VIVITROL.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent
- •Willing and able to provide government-issued identification
- •Has a Body Mass Index (BMI) of 18.0-40.0 kg/m^2
- •Has a history of opioid use disorder diagnosis for at least 6 months
- •Has a history of prescribed buprenorphine (or buprenorphine/naloxone) maintenance for the prior 3 or more consecutive months and is currently buprenorphine-maintained
- •Must be voluntarily seeking treatment for opioid use disorder and be motivated to receive antagonist therapy
- •Willing to abide by the contraception requirements for the duration of the study
- •Additional criteria may apply
排除标准
- •Is pregnant, planning to become pregnant or breastfeeding during the study
- •Has a positive urine drug screen for opiates or oxycodone at screening
- •Has used methadone within 30 days prior to study Day -5
- •Has used naltrexone (oral or VIVITROL) within the 90 days prior to Day -5
- •Has a history of seizures or has received anticonvulsant therapy within the past 5 years for treatment of seizures (use of anticonvulsant during the past detoxification is not exclusionary)
- •Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
- •Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
- •Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
- •Has a history of hypersensitivity or adverse reaction to buprenorphine, naltrexone, VIVITROL, or naloxone
- •Additional criteria may apply
研究组 & 干预措施
PBO NTX + BUP
Placebo naltrexone + buprenorphine
干预措施: Buprenorphine (Drug)
PBO NTX + BUP
Placebo naltrexone + buprenorphine
干预措施: Placebo (Drug)
NTX + BUP
Naltrexone + buprenorphine
干预措施: Naltrexone (Drug)
NTX + BUP
Naltrexone + buprenorphine
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8
时间窗: 8 days
Demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe).
次要结局
- Incidence of Adverse Events (AEs)(Up to 42 days)
- Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal(Days 9-11)
- Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7)(Up to 7 days)
- Proportion of Days With COWS Peak Score </=12 During the Treatment Period Prior to the VIVITROL Injection(1 week)
- Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period(The COWS was administered 4-6 times per day during the Treatment Period)
- Mean Score for "Desire for Opioids" Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period(Up to 11 days)