NCT00027079已完成2 期
Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2001年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
研究概览
简要总结
This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •Current diagnosis of alcohol dependence.
- •Provide a written informed consent.
- •Must weigh within 30% of their ideal body weight.
- •Patients must weigh at least 89 lbs. and no more than 342 lbs.
- •Good physical health.
- •Currently drinking 14 or more alcohol units per week for women and 21 or more alcohol units per week for men in the last 30 days.
- •Provide evidence of stable residence in the last month prior to enrollment in the study.
- •No plans to move in the nine months after entering the study.
- •Literate in English and able to read, understand, and complete questionnaires and follow instructions.
- •Willingness to participate in behavioral treatment for alcoholism.
排除标准
- •Current psychiatric disorder other than alcohol or nicotine dependence.
- •Elevated liver enzymes or elevated bilirubin.
- •Severe alcohol withdrawal symptoms which require treatment.
- •Serious medical co-morbidity requiring medical intervention or close supervision.
- •Severe or life-threatening adverse reactions to medications in the past or during this trial.
- •Female patients 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.
- •Compelled to participate in an alcohol treatment program for alcohol dependence to maintain their liberty.
- •Members of the same household.
- •Tuberculosis.
- •Current treatment with any medications having a potential effect on alcohol consumption and related behaviors or mood.
- •Urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
- •Pyrexia of unknown origin.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Combined Pharmacotherapies for AlcoholismAlcoholismNCT00768508Bankole Johnson300
Unknown
2 期
Alcohol Dependency Study: Combining Medication Treatment for AlcoholismAlcoholismNCT00006205Bankole Johnson320
已完成
2 期
Sertraline and Naltrexone for Alcohol DependenceAlcoholismNCT00000440National Institute on Alcohol Abuse and Alcoholism (NIAAA)124
已完成
4 期
Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)AlcoholismAlcohol DependenceDepressionNCT00006204National Institute on Alcohol Abuse and Alcoholism (NIAAA)106
已完成
4 期
Naltrexone Treatment for AlcoholismAlcoholismNCT00000438Johns Hopkins University192