A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Medisorb® Naltrexone in Alcohol-Dependent Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 624
- 主要终点
- Percentage of Heavy Drinking Days Over the Treatment Period
研究概览
简要总结
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.
详细描述
All subjects received standardized biopsychosocial support therapy (BRENDA Approach [Volpicelli, JR [2001]; Guilford Press: New York]) at each visit.
Subjects who completed this study (ie, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the option to enroll in extension study ALK21-003EXT (NCT01218971). A second extension, Study ALK21-010 (NCT00156923), was conducted subsequent to ALK21-003EXT.
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
- •Diagnosis of alcohol dependence based on Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria
- •Male or non-pregnant, non-lactating female
- •Able to provide TimeLine Follow-Back (TLFB) alcohol consumption information for 90-day period before detoxification and/or screening
- •At least 2 episodes of heavy alcohol drinking per week during the 30 days before detoxification and/or screening
- •Negative urine toxicological screen for opiates on day of randomization
- •Noncustodial, stable residence and phone plus 1 contact with verifiable address and phone
排除标准
- •Evidence of hepatic failure including: ascites, prolonged prothrombin time (PT) (international normalized ratio [INR] ≥1.7), bilirubin >10% above upper limit of normal (ULN) and/or esophageal variceal disease
- •Active hepatitis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than 3xULN
- •History of pancreatitis
- •Major depression with suicidal ideation, psychosis, bipolar disorder, or psychiatric disorders that would compromise subject's ability to complete the study
- •Current dependence (within past year) per DSM-IV criteria to benzodiazepines, opioids or cocaine
- •Use of benzodiazepines and/or Ambien® (zolpidem tartrate) within 7 days prior to first dose of study medication
- •Greater than 7 days inpatient treatment for substance use disorders within 30 days of randomization
- •Use of any opioids and/or methadone within 14 days of screening, or likely requiring opioid therapy during study period
- •Use of oral naltrexone or disulfiram within 14 days of screening
- •Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)
研究组 & 干预措施
Medisorb naltrexone 380 mg
干预措施: Medisorb naltrexone 380 mg (Drug)
Medisorb naltrexone 190 mg
干预措施: Medisorb naltrexone 190 mg (Drug)
Placebo for Medisorb naltrexone 190 mg
干预措施: Placebo matching Medisorb naltrexone 190 mg (Drug)
Placebo for Medisorb naltrexone 380 mg
干预措施: Placebo matching Medisorb naltrexone 380 mg (Drug)
结局指标
主要结局
Percentage of Heavy Drinking Days Over the Treatment Period
时间窗: Baseline through Week 24 (168 days)
Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women.
次要结局
- Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)(24 weeks (Baseline to Week 24))