A Direct-to-Consumer, Randomized, Double-blind, Placebo-controlled, Double Cross-over Study Investigating the Effect of Specific Cannabinoid Products on Motivation, Energy Level, Focus, and Appetite in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- To observe the effect of various cannabinoid-containing products on motivation.
研究概览
简要总结
Tetrahydrocannabivarin (THCV) is a rare cannabinoid and is a homologue of THC that differs only in the length of the alkyl side chain (3C vs 5C, respectively). Pre-clinical and clinical trials have shown that THCV has medical potential as a neuroprotectant, anti-inflammatory, anti-anxiety, and most notably as a therapeutic to improve glycemic control in type 2 diabetic patients.
Several THCV products are available in states with recreational cannabis. Anecdotal reports from adult cannabis users indicate that THCV provides an energizing, focusing and euphoric high-while still creating a lucid, uplifting experience. Additionally, unlike THC-dominant products, THCV was not reported to increase appetite. Other anecdotal comments referring to increased ability to focus for long periods of time and being more active were common.
Given anecdotal evidence, which shows that THCV is activating and improving focus, this provides rationale and justification to conduct a clinical research study to further test and understand whether THCV improves motivation, focus, level of energy, and does not stimulate appetite in healthy adults.
详细描述
The rationale for this study is to determine the effect of a consumer-grade, state-legal formulation of cannabinoids including Tetrahydrocannabivarin (THCV) on motivation, energy level, focus, and appetite. A consumer-driven, decentralized observational clinical research study is therefore well suited to examine the effect of this formulation in healthy individuals.
The investigators will examine the outcomes in a broad age-range of adults who have chosen to try these products. The study will incorporate participant reported outcomes and surveys collected after each product use session to engage the participant in their typical day-to-day activities. There is no "physician-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the products and take part in the observational process with self-reported measures. Findings from this study will contribute knowledge toward the design of future cannabis research studies and the improvement of the product formulation.
A new study questionnaire was developed as no existing questionnaire would be able to capture all interest areas of this study in a holistic manner. Other questionnaires related to focus, attention, concentration, fatigue, work, and motivation were assessed and used to support the study questionnaire development.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults age > 21 years old
- •Work / study / play in an environment that requires focus
- •Able to read and understand English
- •Able to read, understand, and provide informed consent
- •Able to use a personal smartphone device and download Chloe by People Science
- •Able to complete study assessments over the course of up to 14 days
- •Familiar with the use of cannabis and its effects
- •Able to tolerate at least 5mg THC
- •Willingness to abstain from use of any THC containing products during study product use days
- •Willingness to abstain from use of alcohol during study product use days
- •Greater Los Angeles area residents only
排除标准
- •Participants who do not have a smartphone and/or internet access
- •Any known adverse effects from taking cannabis
- •Concomitant Therapies: Currently taking medication for ADHD or psychotropic medications
- •Other Illnesses or Conditions: Participants who have the following co-morbidities are excluded:
- •History or currently undergoing product use for substance abuse disorders
- •Currently pregnant, planning to become pregnant within the next month, or breastfeeding
- •Allergies to formulation ingredients
- •Current or prior psychotic disorder
- •Immunosuppressive product uses, including organ transplant participants, active immunotherapy for cancer product use
- •Any condition that is considered by investigator to be a contraindication to cannabis (e.g. specific drug-use interaction, unstable cardiac arrhythmia)
结局指标
主要结局
To observe the effect of various cannabinoid-containing products on motivation.
时间窗: 3 weeks
Change in average motivation score by 1 point as measured by a 10-point visual analogue rating scale (VAS) collected between cannabinoid and placebo use sessions. The scale is between 1-10, where 1 denotes 'Strongly Disagree' and 10 denotes 'Strongly Agree.'
次要结局
- To observe the effect of cannabinoid products on motivation, energy level, focus, and appetite (MEFA).(3 weeks)