A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Adaptive Study of the Safety and Efficacy of RDC-0313 in Adults With Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 406
- 试验地点
- 2
- 主要终点
- Percent of subjects abstinent from heavy drinking
研究概览
简要总结
This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit.
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled study. A 3-stage adaptive design will be used. Following screening, eligible subjects will be randomized equally to 1 of 4 groups (ALKS33 [RDC-0313] [1, 2.5, OR 10 mg], or matching placebo).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Current diagnosis of alcohol dependence, with recent heavy drinking (eg, 5 drinks per day for men and 4 drinks per day for women)
- •A noncustodial stable residence and a telephone
- •Women having reproductive potential must agree to use an approved method of contraception for the duration of the study
- •Ability to stop drinking prior to receiving study drug
排除标准
- •Pregnancy and/or current breastfeeding
- •Past or present history of an AIDS-indicator disease
- •Current dependence on any drugs (exclusive of nicotine, caffeine, or alcohol)
- •Positive urine drug screen for benzodiazepines (unless used for a short-term basis during alcohol detoxification), opioids, amphetamines/ methamphetamines or cocaine at Visits 1 and 2
- •Clinically significant medical condition
- •Current or anticipated need for prescribed opioid medication during the study period
- •Use of naltrexone within 60 days prior to screening
- •Current need for antidepressants (within 30 days prior to entry)
- •Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
- •Parole or probation or pending legal proceedings that have the potential for incarceration during the study period
研究组 & 干预措施
ALKS33 (RDC-0313) (1 mg)
1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
干预措施: ALKS33 (RDC-0313) (1 mg) (Drug)
ALKS33 (RDC-0313) (2.5 mg)
2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
干预措施: ALKS33 (RDC-0313) (2.5 mg) (Drug)
ALKS33 (RDC-0313) (10 mg)
10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
干预措施: ALKS33 (RDC-0313) (10 mg) (Drug)
Placebo
Matching placebo (capsules without active study drug) provided for daily oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of subjects abstinent from heavy drinking
时间窗: 12 Weeks
次要结局
- Percent of subjects abstinent from any drinking(12 Weeks)
- Percent of days abstinent from heavy drinking(12 Weeks)
- Percent of days abstinent from any alcohol(12 Weeks)
- Number of drinks per drinking day(12 Weeks)
- Days to relapse to first heavy drinking day(12 Weeks)
- Incidence of Adverse Events(12 Weeks)