Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Alcohol Self-Administration During the Bar Lab Task
研究概览
简要总结
The goal of this study is to learn how CBD affects drinking in people who drink alcohol regularly. Researchers want to see if CBD can help people drink less and reduce problems related to alcohol use.
详细描述
Your participation will include up to five in-person visits over about 13 weeks, including a screening visit, a visit to get your medication, a midpoint visit, an experimental lab session, and a final follow-up visit. You will be assigned to a study medication which you will take daily for 8 weeks while completing daily surveys and weekly virtual check-ins with the research team. During the experimental lab session visit, you will be offered alcohol to drink at the bar lab.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have used CBD and cannabis at least once in the last year
- •Regularly drink alcohol
- •Able to provide informed consent and attend in-person study visits
排除标准
- •Current use of medications known to have major interaction with Epidiolex, Marinol, or alcohol
- •Current use of antiepileptic medication or any psychotropic medication besides antidepressants
- •Pregnant, nursing, or planning a pregnancy
- •Medical conditions that contraindicates the use of CBD or alcohol
- •Current medical conditions that may require intensive care during the study period
- •Not everyone will qualify to be in the study. Other inclusion and exclusion criteria will be evaluated by the study team.
研究组 & 干预措施
Placebo
Subjects will take a matching placebo solution (100% Hemp Seed Oil) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the condition will take approximately 100mg hemp seed oil in the morning (2 capsules) and 100mg hemp seed oil in the evening (2 capsules).
干预措施: Placebo (Drug)
Full-Spectrum CBD
Subjects will take 200 mg of full-spectrum CBD ([fsCBD] CBD that contains <0.3% THC) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the fsCBD condition will take approximately 100mg fsCBD in the morning (2 capsules) and 100mg fsCBD in the evening (2 capsules).
干预措施: Full-Spectrum Cannabidiol (CBD) (Drug)
Broad- Spectrum CBD
Subjects will take 200 mg of broad-spectrum CBD ([bsCBD] CBD that contains no THC) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the bsCBD condition will take approximately 100mg bsCBD in the morning (2 capsules) and 100mg bsCBD in the evening (2 capsules).
干预措施: Broad-Spectrum Cannabidiol (CBD) (Drug)
结局指标
主要结局
Alcohol Self-Administration During the Bar Lab Task
时间窗: Week 8
Number of drinks (between 0-8) subjects choose to self-administer during the Bar Lab Alcohol Self-Administration Task at the week 8 study visit.
Change in Self-Report of Drinking Behavior (Drinks Per Drinking Day)
时间窗: Baseline, Week 4, Week 8, and Week 12
Drinks Per Drinking Day (DPDD) during the 12-week study period as reported on Timeline Follow Back at Baseline (prior to treatment), Week 4, Week 8, and Week 12.
Change in Phosphatidylethanol (PEth)
时间窗: Baseline, Week 4, Week 8, and Week 12
Phosphatidylethanol (PEth) concentration in blood samples collected at Baseline (prior to treatment), Week 4, Week 8, and Week 12.
次要结局
- Change in Negative Emotionality ANA Domain Score(Baseline, Week 8)