A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
研究概览
简要总结
The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).
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
- 是
入选标准
- •The subject must be at least 18 years of age.
- •The subject must have a DSM-IV diagnosis of current alcohol dependence.
- •The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
- •The subject must be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- •If the subject is female and of child bearing potential, she must agree to use at least one of the following methods of birth control, or she must be surgically sterile or postmenopausal:
- •oral contraceptives
- •contraceptive sponge
- •barrier (diaphragm or condom)
- •intrauterine contraceptive system
- •levonorgestrel implant
- •medroxyprogesterone acetate contraceptive injection
- •complete abstinence from sexual intercourse, and/or
- •hormonal vaginal contraceptive ring.
- •The subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
- •The subject must complete all psychological assessments required at screening and baseline.
- •The subject must provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
- •The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.
排除标准
- 未提供
研究组 & 干预措施
Levetiracetam XR
Group received Levetiracetam
干预措施: BBCET (Behavioral)
Levetiracetam XR
Group received Levetiracetam
干预措施: Levetiracetam XR (Drug)
Sugar Pill
Placebo
干预措施: BBCET (Behavioral)
Sugar Pill
Placebo
干预措施: Sugar Pill (Drug)
结局指标
主要结局
The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
时间窗: Study Weeks 5-14
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
时间窗: Weeks 5-14
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
次要结局
- The Number of Drinks Per Drinking Day Study Weeks 5-14.(Study Weeks 5-14)