A Placebo-controlled, Triple-blind, Pre-post Interventional Study of Swallowable Cannabigerol Tablets on Sleep Quality in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Medical Outcomes Study (MOS) Sleep Problems Index II
研究概览
简要总结
New methods for the treatment and support of Veterans experiencing sleep issues is critically needed. LEVEL's unique, targeted effects-based cannabis products provide a unique opportunity to study the therapeutic safety and efficacy of cannabigerol (a non-psychoactive cannabinoid) with a controlled dosage. Study participants will participate in an interventional, placebo-controlled, triple-blind pre-post study design. Participants will have a four-week run-in phase followed by an eight-week treatment phase with a CBG ProtabTM or placebo ProtabTM in a swallowable tablet form. During the study, participants will answer questions assessing their sleep, alcohol and drug use, and quality of life, among others. They will also wear a Fitbit Inspire 2 to collect biometric data.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Veteran status
- •MOS Sleep Problems Index II > 30
- •California resident
- •Participants must own their own smartphone device to use for the study. Devices must meet the following criteria:
- •Participants must be comfortable reading study instructions in English and communicating with study team in English
- •Be willing to commit to study dosing, completing evaluation instruments, and following study protocol activities.
- •If female and of childbearing potential, agree to use an effective form of birth control during study participation.
排除标准
- •If using sleep medications, medication and dosage have not been changed in the past month and will remain unchanged for the duration of the study
- •If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the study
- •Prior observation that the prospective participant has stopped breathing or observed choking/gasping during their sleep
- •Previous diagnosis of sleep apnea (participant reported) without use of a CPAP (or similar PAP device) for at least the prior 4 weeks
- •Currently in a Cognitive Behavioral Therapy for Insomnia (CBTI) program
- •Women who are currently pregnant, trying to become pregnant, or breastfeeding
- •Currently using CBG on a regular basis
- •Participant has already participated in this study
结局指标
主要结局
Medical Outcomes Study (MOS) Sleep Problems Index II
时间窗: 4 weeks
Change in sleep quality from baseline scores as measured by the Medical Outcomes Study (MOS) Sleep Problems Index II after 4 weeks. Scores range from 0-100, with higher scores indicating a worse outcome.
次要结局
- WHO-DAS-2.0-12(4 weeks)
研究者
Chris Emerson
CEO & Founder
Metta Medical, Inc