Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults With Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Peripheral IL-6 Concentration
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of oleoylethanolamide (OEA) supplementation on inflammation, the oral microbiome, neurocognitive function, and alcohol use in young adults ages 18 to 25 with alcohol use disorder (AUD). The main questions it aims to answer are:
- Does OEA reduce peripheral markers of immune activation (IL-6, TNF-α, IL-1β, and LPS)?
- Does OEA alter oral microbiome composition?
- Does OEA improve neurocognitive measures of reward sensitivity and impulsivity?
Researchers will compare OEA to a placebo (a look-alike substance with no active ingredient) to determine whether OEA improves biological and behavioral outcomes associated with AUD.
Participants (N = 42) will:
- Be randomly assigned to receive 300mg TRIPTI (providing 250 mg/day of OEA) or placebo for 6 weeks.
- Provide blood, saliva, and urine samples
- Complete cognitive testing and questionnaires
- Report alcohol use during the study
- Attend in-person study visits for monitoring and assessments
This randomized, double-blind, placebo-controlled pilot trial will provide preliminary data on the potential efficacy of OEA as a multi-system intervention for young adults with AUD.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to
- •Call study team for additional screening and information.
排除标准
- 未提供
研究组 & 干预措施
OEA
Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide [OEA]) orally for 6 weeks.
干预措施: oleoylethanolamide (Drug)
Placebo
Participants receive a matching placebo capsule orally once daily for 6 weeks.
干预措施: oleoylethanolamide (Drug)
结局指标
主要结局
Change in Peripheral IL-6 Concentration
时间窗: Baseline and week 6
Blood-based concentration of interleukin-6 (IL-6) measured using immunoassay methods to assess systemic inflammation. Unit of Measure: pg/mL
Change in Peripheral TNF-α Concentration
时间窗: Baseline and week 6
Blood-based concentration of tumor necrosis factor-alpha (TNF-α) measured using immunoassay methods to assess systemic inflammation.Unit of Measure: pg/mL
Change in Peripheral IL-1β Concentration
时间窗: Baseline and week 6
Blood-based concentration of interleukin-1 beta (IL-1β) measured using immunoassay methods to assess systemic inflammation. Unit of Measure: pg/mL
Change in Plasma Lipopolysaccharide (LPS) Levels
时间窗: Baseline and week 6
Alpha diversity indices derived from sequencing of saliva samples to assess oral microbiome composition. Unit of Measure: pg/mL
次要结局
- Change in Oral Microbiome Alpha Diversity(Baseline and Week 6)
- Change in Oral Microbiome Beta Diversity(Baseline and Week 6)
- Change in Reward Sensitivity(Baseline and Week 6)
- Change in Impulsivity(Baseline and Week 6)
研究者
Brittney Browning
Assistant Professor-Faculty
Medical University of South Carolina