NCT00011297已完成2 期
Alcohol Research Center - Treatment and Implications
National Institute on Alcohol Abuse and Alcoholism (NIAAA)2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2001年2月19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
- 160
- 试验地点
- 2
研究概览
简要总结
This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome.
- •Subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days).
- •Have a clinical withdrawal assessment prior to study.
- •Must be medically acceptable for study treatment. Considerations include no past or present physical disorder that is likely to deteriorate during participation. No ECG abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment.
- •Able to read, write, and speak English.
- •Have a negative urine drug screen for benzodiazepines or other sedative hypnotics, opiates, and stimulates prior to entering the study.
排除标准
- •Current diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine and caffeine dependence).
- •Use of pharmacological agents within the last 14 days that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome.
- •History of alcohol withdrawal seizures, epilepsy or delirium tremens.
- •Diagnosis of schizophrenia, bipolar disorder or dementia.
- •Liver function tests higher than normal.
- •History of hepatic encephalopathy, jaundice, ascites, diabetes, or renal disease.
- •Females who are pregnant or nursing.
- •Subjects with known sensitivity of previous adverse reaction to gabapentin, lorazepam, or other benzodiazepines.
- •History of severe GI disease which might render absorption of the medication difficult or produce medical instability of the patient during detoxification which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of GI bleeding.
- •Unable to provide an informed consent.
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
Efficacy of outpatient treatment of alcohol use disorderAlcohol use disorder.A cluster of behavioural, cognitive, and physiological phenomena that develop after repeated substance use and that typically include a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequencesIRCT20170702034844N3Tehran University of Medical Sciences31
已完成
不适用
Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary ChoicesEating HabitHealthy DietNCT05303207Your Super, INC.38
Enrolling By Invitation
不适用
Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without AntibioticsDiverticulitis, ColonicNCT06517264Monica Mengual Ballester282
已完成
3 期
Efficacy and Safety Study of an Oral Contraceptive in Healthy FemalesContraceptionNCT00206583Bayer499
进行中（未招募）
不适用
DEB for Symptomatic Intracranial Atherosclerosis StenosisCerebral IschemiaCerebral AtherosclerosisNCT04821726Yinyi(Liaoning) Biotech Co., Ltd.155