NCT00678457已完成2 期
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics.
研究概览
简要总结
This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.
详细描述
Target population: We will enroll male and female who meet DSM IV criteria for alcohol dependence and who are currently drinking equal or more than 21 alcohol units/week for women and equal or more than 28 alcohol units/week for men in the 7 day period prior to enrollment.
This is a double-blind placebo-controlled study. Eligible subjects will be randomized to ondansetron (4 ug/kg) and olanzapine (9, 18, 36 ug/kg) vs placebo. All subjects will participate in a 9 week regimen of weekly BBCET and outpatient medication treatment.
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 —（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
- •Aged 18 years and above and weighing ≥40 kg and ≤140 kg
- •Drinking on average ≥21 and ≥28 drinks/week for women and men, respectively, in the 7-day period prior to enrollment
- •DSM-IV-R diagnosis of alcohol dependence
- •Good physical health as determined by a complete physical examination, electrocardiogram (EKG) within normal limits and laboratory screening tests within acceptable range
- •Negative pregnancy test at intake.
- •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
- •Willing to participate in behavioral treatments for alcoholism
- •Answer an advertisement in the newspaper/radio/television, and express a wish to stop drinking
- •Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next three months
排除标准
- •Any current axis I DSM-IV psychiatric disorder other than alcohol or nicotine dependence that warrants treatment or would preclude safe participation in the protocol
- •Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment
- •Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of ondansetron or olanzapine
- •Severe or life-threatening adverse reactions to the ondansetron or olanzapine medications in the past or during this clinical trial
- •Female subjects who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study
- •Received inpatient or outpatient treatment for alcohol dependence within the last 30 days
- •Significant medical illness (including hypertension) as determined by history and/or complete physical examination.
- •Gross neurological disease
- •Mental retardation
- •Pyrexia of unknown origin
- •Diagnosis or suspicion of Alzheimer's disease
- •Clinically significant abnormalities on the EKG that will preclude safe participation
- •Recent (last 3 months) history of ischemic heart disease or myocardial infarction.
- •Current infective hepatitis as evidenced by clinical manifestations. If hepatitis is suspected, a hepatitis antibody/antigen screen will be done.
- •Participation in a clinical study within the last 30 days
- •Elevation of liver enzymes
- •History of any severe or life-threatening reaction to olanzapine or ondansetron
- •Past or current history of seizures disorder
- •Past or current history of diabetes
- •Being treated with any medication with potential for clinically significant interactions with alcohol or olanzapine and/or ondansetron. These include:, serotonin antagonists (e.g., ritanserin or buspirone), dopamine antagonists (e.g., haloperidol), or compounds with actions similar to disulfiram (Antabuse®).
- •Pending imprisonment
研究组 & 干预措施
ondansetron/olanzapine
Experimental
ondansetron (4 μg/kg b.i.d.)
olanzapine (9 μg/kg)
干预措施: Ondansetron (Drug)
ondansetron/olanzapine
Experimental
ondansetron (4 μg/kg b.i.d.)
olanzapine (9 μg/kg)
干预措施: Olanzapine (Drug)
placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics.
时间窗: Throughout the study
次要结局
- The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking.(Throughout the study)
研究者
研究点 (2)
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