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

NCT06213064 | Unknown

• 1 other identifier: PS04
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To observe the effect of cannabinoid products on motivation, energy level, focus, and appetite (MEFA).

  3 weeks

Other Outcomes (1)

• To observe changes in overall symptoms and quality of life.

  3 weeks

Study Arms (1)

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.

Behavioral: Study Product, THC Product, Placebo

Interventions

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.

Study Product, THC Only Product, Placebo

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample size for this study will be approximately 58 healthy volunteers who meet the eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Phylos Bioscience, Inc.: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science, Inc.

Los Angeles, California, 90034, United States

RECRUITING

Study Officials

• Noah Craft, MD

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Kazaryan, MPhil

CONTACT

8184528996; amy@peoplescience.health

Crisel Erfe, MD

CONTACT

310-922-0609; crisel@peoplescience.health

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: January 19, 2024
• Study Start: August 14, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

US (1)