Recruiting

Cannabinoid Products

Sponsor:

Phylos Bioscience, Inc.

Code:

NCT06213064

Conditions

Motivation

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Study Product, THC Product, Placebo

Study Details

Brief summary:

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.

Conditions

Motivation

Study ID

NCT06213064

Start date

Aug 14, 2023

Status verified date

Jan, 2024

Completion date

Jun 1, 2024

Anticipated

Primary completion date

Mar 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy adults age > 21 years old
2. Work / study / play in an environment that requires focus
3. Able to read and understand English
4. Able to read, understand, and provide informed consent
5. Able to use a personal smartphone device and download Chloe by People Science
6. Able to complete study assessments over the course of up to 14 days
7. Familiar with the use of cannabis and its effects
8. Able to tolerate at least 5mg THC
9. Willingness to abstain from use of any THC containing products during study product use days
10. Willingness to abstain from use of alcohol during study product use days
11. Greater Los Angeles area residents only

Exclusion Criteria:

1. Participants who do not have a smartphone and/or internet access
2. Any known adverse effects from taking cannabis
3. Concomitant Therapies: Currently taking medication for ADHD or psychotropic medications
4. Other Illnesses or Conditions: Participants who have the following co-morbidities are excluded:

1. History or currently undergoing product use for substance abuse disorders
2. Currently pregnant, planning to become pregnant within the next month, or breastfeeding
3. Allergies to formulation ingredients
4. Current or prior psychotic disorder
5. Immunosuppressive product uses, including organ transplant participants, active immunotherapy for cancer product use
6. Any condition that is considered by investigator to be a contraindication to cannabis (e.g. specific drug-use interaction, unstable cardiac arrhythmia)

Study Design

Enrollment

58 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Study Product, THC Product, Placebo

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.

Primary outcome measure

  • To observe the effect of various cannabinoid-containing products on motivation. [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Amy Kazaryan, MPhil

8184528996amy@peoplescience.health

Crisel Erfe, MD

310-922-0609crisel@peoplescience.health

Locations

People Science, Inc.

Recruiting

Los Angeles, California, United States, 90034

Contacts

Amy Kazaryan, MPhil

818-452-8996amy@peoplescience.health

Crisel Erfe, MD

310-922-0609crisel@peoplescience.health

Principal Investigator:

Noah Craft, MD

More Information

Sponsor

Phylos Bioscience, Inc.

Last update posted

Jan 19, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phylos Bioscience, Inc. on 2024-01-19.