Medications Development for Alcohol Abuse: NMDA Agents -- A Placebo-Controlled Trial of Memantine for Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Alcohol consumption- Standard Drink Units (Time line Followback)
研究概览
简要总结
The purpose of this study is to obtain a preliminary indication of the safety and effectiveness of oral memantine (40 mg/day) in alcohol dependent patients. This study is a 16-week study comparison of memantine and placebo in patients with alcohol dependence.
详细描述
This study is a 16-week study, double-blind, parallel groups, two arm comparison of memantine and placebo in patients with alcohol dependence.
Procedures. This outpatient clinical trial comprises a 2-week placebo lead-in phase followed by a 12-week treatment phase and a 2-week lead-out phase. Patients will be seen 2x/week. There will also be a 3-month follow-up visit to reassess the status of abstinence or relapse to drinking. The design of the study is as follows:
Single-blind Placebo Lead-in Phase (Week -2 and Week -1). Patients who give informed consent and provisionally meet the inclusion-exclusion criteria will enter a 2-week Single-blind Placebo Lead-in Phase. After this placebo lead-in phase, patients will be randomized to receive memantine or placebo and they will be stratified by sex, age, race and level of alcohol dependence.
12 Week Treatment Phase (Weeks 1-12). At these visits, medication will be provided, standardized assessment instruments will be completed, and biochemical measures will be taken to monitor alcohol consumption as well as compliance with study medication. In one of these two weekly visits patients will receive individual, manual-guided relapse prevention therapy with a clinician and meet with a study psychiatrist. Patients wishing to take naltrexone (ReVia), disulfiram (Antabuse), or participate in more intensive inpatient treatment during the trial will be discontinued from the study.
Single-blind Lead-out Phase (Weeks 13-14). During this 2-week lead-out phase, patients on active medication will be tapered off the medication to placebo, but all other measures and assessments (including weekly psychotherapy sessions) will remain the same. All patients, regardless of whether they complete the study or are administratively removed, will be followed up and rated at Week 14. There will also be a 3-month follow-up visit to reassess the status of abstinence or relapse to drinking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Males or females between the ages of 18-65 yrs.
- •Meets DSM-IV criteria for current alcohol dependence. Volunteers may meet criteria for other substance abuse, or dependence on other drugs (nicotine, marijuana or cocaine) as long as the dependence on marijuana or cocaine is secondary to alcohol dependence
- •Medically healthy on the basis of physical examination and medical history, vital signs, ECG and laboratory tests, with a negative blood pregnancy test for females.
- •Expresses desire to stop drinking alcohol.
- •Does not require any psychotropic medication.
- •Able to provide informed consent and comply with study procedures.
- •Signed informed consent.
排除标准
- •Dependence on opiates
- •Meets DSM-IV criteria for schizophrenia or bipolar Disorder. Has a psychotic illness or is at risk for suicidal behavior.
- •History of delerium tremens (hallucinations, psychosis, agitation) secondary to alcohol withdrawal, a personal or family history of seizure disorder, a personal history of moderate/severe head trauma.
- •Currently taking psychotropic medication.
- •In need of inpatient alcohol detoxification.
- •Any renal disease or insufficiency.
- •Clinically significant and symptomatic medical disorder requiring active intervention
- •Female patients who are lactating or who have childbearing potential and who refuse to use birth control (hormone or barrier) or are pregnant.
- •Patients for whom treatment of alcoholism is being mandated by legal action.
- •Patients with active malignancy (other than non- melanoma skin cancer of carcinoma in situ of uterine cervix) within 5 years of beginning study.
- •Known or suspected hypersensitivity to memantine.
- •Intolerable adverse event during Single Blind Placebo Lead-in Phase.
- •Patients taking naltrexone or antabuse.
结局指标
主要结局
Alcohol consumption- Standard Drink Units (Time line Followback)
Abstinence from alcohol (Time line Followback)
次要结局
- Clinical Global Impression-Alcohol