Combined Pharmacotherapies for Alcoholism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
研究概览
简要总结
This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.
详细描述
We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.
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.
- •Ages 18 years and above and must weigh at least 40 kg and no more than 140 kg.
- •Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters (see exclusion criteria).
- •Current DSM-IV diagnosis of alcohol dependence
- •AUDIT score of equal or more than
- •Currently 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.
- •The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.
- •Literate in English and able to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
- •Answer an advertisement in the newspaper/radio/television, or be referred from a health care professional and express a wish to stop drinking.
- •Willingness to participate in behavioral treatments for alcoholism.
排除标准
- •Any current axis I DSM IV psychiatric disorder other than alcohol or nicotine dependence
- •Elevation of liver enzymes - (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH) greater than four times the normal range, or clinically significant elevated direct bilirubin as deemed by the principal investigator.
- •Severe alcohol withdrawal symptoms which in the physicians opinion requires inpatient treatment.
- •Serious medical co-morbidity requiring medical intervention or close supervision, or any condition which can interfere with the receipt of ondansetron.
- •Severe or life-threatening adverse reactions to medications in the past or during this clinical 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 (support groups such as AA are not exclusionary).
- •Compelled to participate in an alcohol treatment program to maintain their liberty.
- •Members of the same household.
- •Concurrent treatment with any medications having a potential effect on alcohol consumption and related behaviors, or mood. These include: opiate antagonist (e.g. naltrexone), glutamate antagonists (e.g., acamprosate), serotonin re-uptake inhibitors (e.g. fluoxetine), serotonin antagonists (e.g. ritanserin or buspirone), other antidepressants (e.g. tricylic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g. haloperidol), calcium channel antagonists (e.g. isradipine), or compounds with actions similar to disulfiram (antabuse) or nicotine.
- •Before double-blind randomization, urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
- •Pyrexia of unknown origin
研究组 & 干预措施
Ondansetron
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
干预措施: Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy (Drug)
Naltrexone
Naltrexone 50 mg/day + Cognitive Behavioral Therapy
干预措施: Naltrexone 50 mg/day + Cognitive Behavioral Therapy (Drug)
Ondansetron + Naltrexone
Ondansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day + Cognitive Behavioral Therapy
干预措施: Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy (Drug)
Placebo
Placebo + Cognitive Behavioral Therapy
干预措施: Placebo + Cognitive Behavioral Therapy (Other)
结局指标
主要结局
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
时间窗: Throughout the study
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
次要结局
- Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors(Throughout the study)
研究者
Bankole Johnson
Chair of Psychiatry and NB Sciences
University of Virginia