MotivationNCT06213064
A Direct-to-Consumer Study Investigating the Effect of Specific Cannabinoid Products on Motivation, Energy Level, Focus, and Appetite in Healthy Adults
An observational study of Motivation, run by Phylos Bioscience, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample size for this study will be approximately 58 healthy volunteers who meet the eligibility criteria.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
People Science, Inc.
Los Angeles, California, 90034
Amy Kazaryan, MPhil, 818-452-8996, amy@peoplescience.health
Crisel Erfe, MD, 310-922-0609, crisel@peoplescience.health
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Motivation
- Being tested
- Study Product, THC Product, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Product, THC Product, PlaceboBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Study Product, THC Product, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.'
Measured: 3 weeks
Secondary outcomes (1)
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.'
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start14 Aug 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phylos Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213064
- Sponsor's protocol ID
- PS04
- Status last verified
- Jan 2024
- First submitted
- 14 Nov 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data is there own. Participant consent will need to be obtained for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06213064
- Acronym / sponsor ID
- PS04
- Conditions
- Motivation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Phylos Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Product, THC Only Product, Placebo | – | Behavioral: Study Product, THC Product, PlaceboAll 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size for this study will be approximately 58 healthy volunteers who meet the eligibility criteria.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Product, THC Product, PlaceboParticipants 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. | Behavioural | Study Product, THC Only Product, Placebo |
Primary outcome
To observe the effect of various cannabinoid-containing products on motivation.
Time frame: 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.'
1 secondary outcome
To observe the effect of cannabinoid products on motivation, energy level, focus, and appetite (MEFA).
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data is there own. Participant consent will need to be obtained for other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, MD principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motivation, run by Phylos Bioscience, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Kazaryan, MPhil (8184528996, amy@peoplescience.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the effect of various cannabinoid-containing products on motivation. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.