Glutamate-opioid Interactions in Alcohol Drinking Behaviors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Sedation Response to Alcohol at Lab Session
研究概览
简要总结
The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.
详细描述
Participants will be randomized to receive a combination of naltrexone/memantine over a one week period and then participate in a laboratory session. During this session, participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. These medications are hypothesized to reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 21-55
- •Able to read English at 6th grade level or higher and to complete study evaluations
- •Regular alcohol drinker
排除标准
- •Individuals who are seeking alcohol treatment
- •Medical conditions that would contraindicate the use of study medication
- •Regular use of other substances
研究组 & 干预措施
Naltrexone and Placebo
Treatment with naltrexone and placebo first
干预措施: Naltrexone and Placebo first (Drug)
Naltrexone and memantine
Treatment with Naltrexone and memantine first
干预措施: Naltrexone and memantine first (Drug)
Naltrexone and memantine
Treatment with Naltrexone and memantine first
干预措施: Naltrexone and Placebo first (Drug)
Naltrexone and Placebo
Treatment with naltrexone and placebo first
干预措施: Naltrexone and memantine first (Drug)
结局指标
主要结局
Sedation Response to Alcohol at Lab Session
时间窗: 50-230 minutes after the priming drink during lab session
Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES. As a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation.
Craving AUC: Adlib Drinking Phase
时间窗: 50-230 minutes after the priming drink during lab session
Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC.
Number of Drinks Consumed at Lab Session (Day 7)
时间窗: Day 7
Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12.
Stimulation Response to Alcohol at Lab Session
时间窗: 50-230 minutes after the priming drink during lab session
Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC.
Craving AUC: Priming Dose Phase
时间窗: 0-50 minutes after the priming drink
Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge.
Stimulation Response to Alcohol: Priming Dose Phase
时间窗: 0-50 minutes after priming drink
Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.
Sedation Response to Alcohol: Priming Dose Phase
时间窗: 0-50 minutes after priming drink
Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.
次要结局
未报告次要终点