1/2 - Pharmacogenetic Treatments for Alcoholism
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percent heavy drinking days
研究概览
简要总结
Heavy drinking can cause serious health, family, and economic problems. Finding treatments that are effective in decreasing heavy drinking among alcohol-dependent individuals is, therefore, an important scientific and health goal. A novel and important strategy to enhance alcoholism treatment efforts uses a personalized medicine approach to optimize treatment effects by selecting the "right" patient therapeutically and potentially with a minimum of adverse events, for a specific medication.
This study will extend findings from a randomized double-blind clinical trial of ondansetron, in which the medication was found to reduce drinking among individuals with certain genotypes (i.e., forms of DNA, the material that controls the inheritance of characteristics). The proposed study will address a number of limitations in the prior work, including testing the medication in both European-American and African-American samples.
详细描述
This study is a 24 week clinical trial. During the 24 weeks participants will receive either ondansetron or placebo. Participants will also receive Brief Behavioral Compliance enhancement Treatment (BBCET) as their psychosocial adjuct weekly in weeks 1 to 12, and then every 2 weeks in weeks 12 to 24. We will enroll two separate population groups (i.e., African-Americans and European-Americans), each with 128 treatment-seeking, alcohol-dependent individuals in a 24-week clinical trial. Subjects in each of these two population groups (N=128/group) will be randomized into 4 cells (N=32/cell) in a 2 (TT vs. TG or GG) × 2 (ondansetron 4 μg/kg twice daily vs. placebo) factorial design. Group assignment will be achieved using a block randomization procedure that balances the treatment groups on PHDD, age, and gender.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Males and females who have given written informed consent
- •Between the ages of 18 and 65 years and weighing within 30% of ideal body weight. Also, patients must weigh at least 40 kg and no more than 155 kg.
- •Good physical health as determined by a complete physical examination, an electrocardiogram (EKG) within normal limits, and laboratory screening tests within acceptable parameters.
- •Current DSM-IV diagnosis of alcohol dependence
- •AUDIT score of ≥8
- •Currently drinking ≥14 alcohol units/week for women and ≥21 alcohol units/week for men in the last 30 days, and have met this criteria prior to randomization
- •Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next 9 months.
- •Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments
- •Expressed a wish to reduce or stop drinking
- •Willingness to participate in behavioral treatments for alcoholism
排除标准
- •Please contact site for additional information
研究组 & 干预措施
Placebo
干预措施: Placebo + Brief Behavioral Enhancement Treatment (Drug)
Ondansetron
干预措施: Ondansetron + Brief Behavioral Enhancement Treatment (Drug)
结局指标
主要结局
Percent heavy drinking days
时间窗: up to 24 weeks
The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.
次要结局
- Drinks per drinking day(up to 24 weeks)
- Percentage of days abstinent(up to 24 weeks)
- Percentage of subjects with no heavy drinking days(up to 24 weeks)
- Measures of quality of life(Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24))
- Objective measure of treatment measure and adverse event using RNA(We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24)