A Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL®
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 20
- 主要终点
- Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection
研究概览
简要总结
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection 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 BMI of 18.0-40.0 kg/m^2
- •Has a physiologic dependence on opioids
- •Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
- •Wiling 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 used Buprenorphine within 7 days prior to randomization
- •Has used Methadone within 14 days prior to randomization
- •Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
- •Has a history of seizures or has received anticonvulsant therapy within the past 5 years
- •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, or Naloxone
- •Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
- •Has significant suicidal ideation or behavior within the past year
- •Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
- •Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
- •Is court mandated to receive treatment for opioid use disorder
- •Additional criteria may apply
研究组 & 干预措施
NTX/BUP
Oral naltrexone + sublingual buprenorphine
干预措施: NTX/BUP (Drug)
NTX/PBO-B
Oral naltrexone + sublingual placebo
干预措施: NTX/PBO-B (Drug)
PBO-N/PBO-B
Oral placebo naltrexone + sublingual placebo buprenorphine
干预措施: PBO-N/PBO-B (Drug)
结局指标
主要结局
Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection
时间窗: 1 week
Toleration to the injection was 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 Effects(Up to 92 days)
- Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection(1 week)
- Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection(The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7))
- Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection(1 week)
- Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection(1 week)
- Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection(The SOWS was administered 4-6 times per day during the Treatment Period)