Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Cumulative Percentage of Participants by Heavy Drinking Rate
研究概览
简要总结
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.
详细描述
The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.
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
- •Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria
- •Expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization
- •Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to first dose
- •Negative urine toxicological screen for opioids on the day of randomization
- •Women of childbearing potential must agree to use an approved method of contraception for the study duration
排除标准
- •Pregnancy or lactation
- •Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal and/or esophageal variceal disease
- •Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM-IV criteria
- •Use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period
- •Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
- •Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG
- •Parole, probation, or pending legal proceedings having the potential for incarceration during the study period
研究组 & 干预措施
VIVITROL 380 mg
Administered via intramuscular (IM) injection once every 4 weeks.
干预措施: VIVITROL 380 mg (Drug)
Placebo for VIVITROL 380 mg
Administered via IM injection once every 4 weeks.
干预措施: Placebo for VIVITROL 380 mg (Drug)
结局指标
主要结局
Cumulative Percentage of Participants by Heavy Drinking Rate
时间窗: up to 12 weeks
Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A "heavy drinking day" was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell \& Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary).
次要结局
- Longer-term Safety of VIVITROL(up to 1 year)