A Direct-to-Consumer Study Investigating the Effect of Specific Cannabinoid Products on Motivation, Energy Level, Focus, and Appetite in Healthy Adults

Description

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

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Study Overview

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Study Details

Study overview

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.

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

A Direct-to-Consumer Study Investigating the Effect of Specific Cannabinoid Products on Motivation, Energy Level, Focus, and Appetite in Healthy Adults

Condition
Motivation
Intervention / Treatment

-

Contacts and Locations

Los Angeles

People Science, Inc., Los Angeles, California, United States, 90034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

21 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Phylos Bioscience, Inc.,

Noah Craft, MD, PRINCIPAL_INVESTIGATOR, People Science, Inc.

Study Record Dates

2024-06-01