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| Name | Class |
|---|---|
| People Science, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Product, THC Only Product, Placebo | All study participants will receive and cross-over into each group: study product, thc-only product, and placebo groups. Study Product Ingredient List: Active Ingredients: 10mg THCV, 5mg THC Tapioca syrup, sugar, water, pectin, citric acid, natural flavors*, coconut oil, sodium citrate, cannabis extract, soy lecithin, Infused THC Gummy Ingredient List: Active Ingredients: 5mg THC Tapioca syrup, sugar, water, pectin, citric acid, natural flavors*, coconut oil, sodium citrate, cannabis extract, soy lecithin, THC. Non-infused Placebo Gummy Ingredient List: Tapioca syrup, sugar, water, pectin, citric acid, natural flavors*, coconut oil, sodium citrate, soy lecithin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Product, THC Product, Placebo | Behavioral | Participants will complete up to a seven week study consisting of screening period, baseline period, up to a 21-day product use period with a total of 9 product use sessions. Screening assessments, baseline questions, product use period questionnaires, adverse event reporting, and end of study experience survey data will be collected. This study will be conducted remotely and will use a web-based data collection platform, Consumer Health Learning and Organizing Ecosystem (Chloe), by People Science where participants will complete study assessments using the Chloe app during the course of the study. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study. |
| Measure | Description | Time Frame |
|---|---|---|
| To observe the effect of various cannabinoid-containing products on motivation. | 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.' | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To observe the effect of cannabinoid products on motivation, energy level, focus, and appetite (MEFA). | Change in average score by 1 point as measured by a 10-point visual analogue rating scale (VAS) between the cannabinoid and placebo use sessions. The scale is between 1-10, where 1 denotes 'Strongly Disagree' and 10 denotes 'Strongly Agree.' | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To observe changes in overall symptoms and quality of life. | Changes in overall symptoms and quality of life to be assessed based on a qualitative evaluation of study participant experiences. | 3 weeks |
Inclusion Criteria:
Exclusion Criteria:
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:
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The sample size for this study will be approximately 58 healthy volunteers who meet the eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Kazaryan, MPhil | Contact | 8184528996 | amy@peoplescience.health | |
| Crisel Erfe, MD | Contact | 310-922-0609 | crisel@peoplescience.health |
| Name | Affiliation | Role |
|---|---|---|
| Noah Craft, MD | People Science, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People Science, Inc. | Recruiting | Los Angeles | California | 90034 | United States |
Individual participant data is there own. Participant consent will need to be obtained for other researchers.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 27, 2024 | |
| Reset | Aug 23, 2024 | |
| Release | Dec 2, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2023 |
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| Reset | Jan 17, 2025 |
| Nov 14, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2023 | Nov 14, 2023 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2024 | Aug 23, 2024 | |||
| Dec 2, 2024 | Jan 17, 2025 |