NCT01146613已完成2 期
A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers
National Institute on Alcohol Abuse and Alcoholism (NIAAA)5 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Weekly Percentage of Heavy Drinking Days
研究概览
简要总结
The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks 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
- 否
入选标准
- •Be at least 18 years of age.
- •Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.
- •Be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking.
- •Be able to verbalize an 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.
- •Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:
- •oral contraceptives,
- •contraceptive sponge,
- •double barrier (diaphragm/spermicidal or condom/spermicidal),
- •intrauterine contraceptive system,
- •levonorgestrel implant,
- •medroxyprogesterone acetate contraceptive injection,
- •complete abstinence from sexual intercourse,
- •hormonal vaginal contraceptive ring, and/or
- •Be able to take oral medication and be willing to adhere to the medication regimen
- •Complete all assessments required at screening and baseline.
- •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.
- •Be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study.
- •Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document.
- •Be someone who in the opinion of the investigator would be expected to complete the study protocol.
- •Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation.
排除标准
- 未提供
研究组 & 干预措施
Varenicline
Active Comparator
Varenicline Tartrate
干预措施: Varenicline (Drug)
Sugar Pill
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Weekly Percentage of Heavy Drinking Days
时间窗: Weeks 2-13*
Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.
次要结局
未报告次要终点
研究者
研究点 (5)
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