Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period
研究概览
简要总结
The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.
详细描述
This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥ 18 and ≤ 55 years of age
- •Meets Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) criteria for current alcohol dependence
- •Does not desire treatment
- •Alcohol free, as verified by breath alcohol concentration, with a Clinical Institute Withdrawal Assessment (CIWA) ≤ 8, at the time of testing, with no evidence of drinking for at least 3 days but no more than 7 days prior to the cue reactivity session
- •Able to complete and understand questionnaires and study procedures in English
- •Verbal I.Q. estimate ≥ 85
- •Signed informed consent
排除标准
- •Currently meets DSM-IV criteria for dependence on substances other than alcohol or nicotine
- •Significant medical disorders that will increase potential risk or interfere with study participation
- •Sexually active women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
- •Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety disorders
- •Treatment within the month prior to screening with investigational medications or those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents
- •Chronic treatment with any narcotic-containing medications during the previous month or evidence of current opiate use
- •Liver function tests more than three times normal or elevated bilirubin
- •No fixed domicile and/or no availability by telephone or beeper
- •Current involvement in or plans for treatment prior to study completion
- •Patients who have a history of adverse drug reactions to the study drugs or their ingredients
- •Failure to take double-blind medication as prescribed
- •Inability to understand or comply with the provisions of the protocol or consent form
研究组 & 干预措施
1
Acamprosate
干预措施: Acamprosate (Drug)
2
Naltrexone
干预措施: Naltrexone (Drug)
3
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period
时间窗: 1 week
The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.
次要结局
- Change From Baseline in Standard Drinks Per Week at 1 Week(1 week)
- Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1(1 week)
- Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1(1 week)
- Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1(2 weeks)
研究者
Barbara J. Mason
PI
The Scripps Research Institute