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
Conditions: Motivation
Sponsor: Phylos Bioscience, Inc.

People Science, Inc.
ONE
Pilot Observational Research Study Protocol
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
Version Date:
28 June 2023
Protocol Version:
Protocol Number:
01
PS04
Sponsor:
Phylos Bioscience Inc.
2455 NW Nicolai St. STE B-O6
Portland, OR 97210
Principal Investigator:
Noah Craft, M.D., Ph.D.
People Science, Inc.
8605 Santa Monica Blvd,
Suite 85089
West Hollywood, CA 90069
213-328-0919
noah@peoplescience.health
Participating Sites:
People Science, Single Site Study
1

TABLE OF CONTENTS
SECTION
PAGE
1.0 OBJECTIVES AND ENDPOINTS
5
2.0 INTRODUCTION: BACKGROUND INFORMATION & SCIENTIFIC RATIONALE
6
2.1 Introduction/Rationale for Development
6
2.2 Overview of and Rationale for the Study Design
6
3.0 Sample Size, Cohort Characteristics, Eligibility and Involvement
6
3.1 Sample Size and Cohort Characteristics
6
3.2 Eligibility
6
3.3 Duration of Participation and Overview of What is Expected from Participants
7
3.4 Participant Recruitment
7
4.0 STUDY ACTIVITY CALENDAR
8
Table 4.1 Study Calendar
8
5.0 RECRUITMENT, CONSENT AND ENROLLMENT
9
5.1 Recruitment
9
5.2 Consent
9
5.3 Enrollment
9
6.0 STUDY PROCEDURES
9
6.1 Study Overview
9
7.0 DATA COLLECTION AND MANAGEMENT
10
7.1 Data Collection Elements, Source, And Method Of Collection
10
7.2 Data Management
10
7.3 Data Management at Study Completion
11
8.0 CODING OF DATA
11
9.0 STATISTICAL CONSIDERATIONS.
11
9.1 Sample Size Estimation and Justification
11
9.2 Projected Study Timeline - Accrual, Data/Sample Collection, Completion
11
9.3 Evaluable Participants
11
9.4 Covariates and Subgroups
11
9.5 Missing Data
12
9.6 Statistical Analysis Plan
12
9.7 Reporting Conventions
12
9.8 Quality Assurance of Statistical Programing
12
10.0 STUDY COMPLIANCE AND REPORTING OF DEVIATIONS FROM APPROVED PROCEDURES13
11.0 STUDY OVERSIGHT, QUALITY ASSURANCE, AND DATA & SAFETY MONITORING
13
2

12.0 Ethical and Regulatory Considerations
13
12.1 Ethical and Regulatory Standard
13
Ethical Standard
13
Regulatory Standard
13
Institutional Review Board
13
12.2 Risk Benefit Considerations
14
Discomforts, Risks, and Risk Mitigation
14
Risk Level Determination
14
Direct benefit to research participants
14
Importance of the knowledge that may reasonably be expected
14
12.3 Participant Characteristics
14
Research equity
14
Vulnerable Populations
14
12.4 Financial Obligation, Burden, and Compensation to Participants
15
Completing research activities (not from results/findings or injury)
15
Research results or clinical findings arising from research activities
15
12.5 Confidentiality/Sharing/Publication
15
Return or Clinical Use of Research Results
15
Confidentiality
15
Information/Data Retention, Future Use, and Sharing
15
Publication
15
12.6 Alternatives to Participation, Withdrawal, and Early Termination
16
Alternatives to Participation
16
Participant Withdrawal from Research/ Research Activities
16
12.7 Informed Consent, HIPAA Authorization, and California Subject’s Bill of Rights
16
Informed Consent
16
Privacy Authorization
16
State of California Human Experimentation Requirements
16
12.8 Investigator Conflict of Interest
17
13.0 REFERENCES
17
3

Abbreviation
Meaning
AE
App
CFR
Chloe
DTC
GCP
HIPAA
ICH
IRB
MEFA
NIH
PI
THC
THCV
VAS
Adverse Event
Application
Code of Federal Regulations
Consumer Health Learning and Organizing Ecosystem
Direct to Consumer
Good Clinical Practice
Health Insurance Portability and Accountability Act
International Council for Harmonisation
Institutional Review Board
Motivation, Energy Level, Focus, and Appetite Questionnaire
National Institutes of Health
Principal Investigator
Tetrahydrocannabinol
Tetrahydrocannabivarin
Visual Analogue Scale
4

1.0 OBJECTIVES AND ENDPOINTS
Objectives
Endpoints/ Measurements
Primary Objective
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 the
cannabinoid products and placebo use
sessions.
Secondary Objective
To observe the effect of cannabinoid
products on energy level, focus, and
appetite.
Change in average score by 1 point as
measured by a 10-point visual analogue rating
scale (VAS) between the cannabinoid products
and placebo use sessions.
Exploratory Objective
To observe changes in overall symptoms
and quality of life.
To identify improvements for future
participant centered study designs using
participant feedback.
Changes in overall symptoms and quality of
life to be assessed based on MEFA
questionnaire responses.
Evaluation of study participant experiences
based on the experience survey. This may
include design and use of app-based data
collection tools.
2.0 INTRODUCTION: BACKGROUND INFORMATION & SCIENTIFIC RATIONALE
2.1 Introduction/Rationale for Development
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
5

understand whether THCV improves motivation, focus, level of energy, and does not stimulate
appetite in healthy adults.
2.2 Overview of and Rationale for the Study Design
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.
We 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.
3.0 SAMPLE SIZE, COHORT CHARACTERISTICS, ELIGIBILITY AND
INVOLVEMENT
3.1 Sample Size and Cohort Characteristics
The sample size for this study will be approximately 58 healthy volunteers who meet the
eligibility criteria.
3.2 Eligibility
Participants must meet all of the following criteria on screening to be considered eligible to
participate in the study:
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
6

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:
a. History or currently undergoing product use for substance abuse
disorders
b.
Currently
pregnant,
planning
to become pregnant within the next month, or
breastfeeding
c. Allergies to formulation ingredients
d. Current or prior psychotic disorder
e. Immunosuppressive product uses, including organ transplant participants, active
immunotherapy for cancer product use
f. Any condition that is considered by investigator to be a contraindication to
cannabis (e.g. specific drug-use interaction, unstable cardiac arrhythmia)
3.3 Duration of Participation and Overview of What is Expected from Participants
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.
3.4 Participant Recruitment
Participants will be recruited through the People Science community, People Science website,
email outreach and social media channels, in addition to Phylos’ community network. Local
dispensaries may also be used for recruitment purposes, as deemed appropriate by Phylos
and People Science. Advertisements will be in digital format and will link to a study landing
page to enable sign up.
Interested individuals will have already made the decision to try these cannabinoid products.
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4.0 STUDY ACTIVITY CALENDAR
Table 4.1 Study Calendar
Protocol
Activities
Screening(a)
Baseline(b)
Study Duration
Product Use Period 1(c)
(Up to 7 Days)
Product Use Period 2(c)
(Up to 7 Days)
Product Use Period 3(c)
(Up to 7 Days)
Up to
Day -14
Up to
Day 14
Product
Use
Session
1
Product
Use
Session
2
Product
Use
Session 3
/ Cross-
Over
Product
Use
Session1
Product
Use
Session 2
Product
Use
Session 3
/ Cross-
Over
Product
Use
Session1
Product
Use
Session 2
Product
Use
Session 3 /
End of
Study(i)
Informed Consent
X
Medical History
X
Demographics
X
Concomitant
Medications
X
Eligibility Confirmation
X
Product Delivery
Receipt
X
Randomizationd
(Study Product, THC
Only Product, or
Placebo Group)
X
MEFA Questionnairee
X
X
X
X
Daily Product Use
Surveyf
X
X
X
X
X
X
X
X
X
Adverse Event
Surveyg
X
X
X
X
X
X
X
X
X
Cross-Overh
(Study Product, THC
Only, or Placebo Group)
X
X
Experience Survey
X
a. Screening activities to occur within 14 days prior to Baseline (Day -14).
b. Baseline activities to occur up to 14 days prior to study product use sessions (Day 14).
c. Study duration to take place up to 21 days total across 7 days maximum within 3 periods.
d. Participants to be randomized into the Study Product, THC-Only Product, and Placebo groups for each
Product Use Period.
e. MEFA (Motivation, Energy Level, Focus, and Appetite) Questionnaire to be administered during Baseline and
at the end of Product Use 3 sessions.
f. Daily Product Use Surveys to be administered at the end of each product use session.g. Any adverse event
occurrence to be reported after the product use session.
h. Participants cross-over into either Study Product, THC-Only Product, or Placebo group upon completion of
Product Use Period 1 and 2.
i. Participants to complete an experience survey at the end of the study.
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5.0 RECRUITMENT, CONSENT AND ENROLLMENT
5.1 Recruitment
Participants will be recruited through the People Science community, social media channels,
including Facebook, Reddit, Instagram, and Google. In addition, People Science will leverage
Phylos’ community network for recruitment purposes, as deemed appropriate.
Recruitment outreach will consist of IRB approved advertising by email, digital flyers/postcards,
and digital marketing channels (email and social media).
The IRB approved study landing page on the People Science website will lead to an IRB
approved
pre-screening
questionnaire
to
determine
individual
qualification
then
collect
participant first and last name, email, phone number, and zip code of qualified individuals. New
leads will receive further instructions by email to determine qualification and continue through
the enrollment process.
5.2 Consent
Virtual electronic informed consent, including a study specific privacy authorization and the
California Experimental Subject’s Bill of Rights will be provided to participants through a HIPAA
compliant cloud-based platform to obtain electronic consent that will ensure that the consenting
process follows all required elements (see Section 7.0). A digital copy of the signed consent will
be stored with the participant’s profile in the study data platform which is the same technology
used for electronic consent.
5.3 Enrollment
Eligible participants who provide virtual electronic consent will be automatically registered into
the study by the data platform (see Section 12.6).
6.0 STUDY PROCEDURES
6.1 Study Overview
Upon initial qualification, the participant will receive an email with study onboarding information
including instructions to complete study assessments, as required. These study assessments
can be accessed via the Chloe mobile app available on Apple iOS and Android devices. The
participant’s activities are as follows:
Screening Day -14 to Day 0:
●
Complete the Informed Consent
●
Complete Demographics, Medical History and Concomitant medications, including current
cannabis use information (frequency, route, any previous adverse reactions from taking
cannabis and tolerance in taking at least 5mg THC previously)
●
Eligibility Confirmation and Enrollment
Baseline Day 1 to Day 14:
●
Provide preferred delivery address for product delivery during Baseline
●
Random assignment to either Study Product, THC-Only Product, or Placebo Group
●
MEFA Questionnaire
●
Receipt of study products within 2 weeks of eligibility confirmation
○
Participants will be asked daily if they have received their study product delivery
○
Once they confirm receipt, they will be advised on the product use period start date
Product Use Period (Up to 21 days):
●
The Participant will be randomized into either Study Product, THC-Only Product, or
Placebo Group upon enrollment
9

●
The Participant will be crossed-over twice into the Study Product, THC-Only Product, or
Placebo Group once they have completed 3 product use sessions during the first and
second product use periods
●
The Participant will complete a total of 9 product use sessions between Study Product,
THC-Only Product, and Placebo groups across a maximum of 21 days
○
The Study Product will contain 10mg THCV + 5mg THC in the form of a single gummy.
●
If the participant cannot tolerate or is not comfortable with 10mg THC based on cannabis
use information collected at screening, the participant may opt to cut the gummy in half
and be advised to use the same dose for all product use days for the duration of the study.
Period 1: Up to 7 days
●
After 3 product use sessions:
○
Daily survey questions regarding motivation, level of energy, focus and appetite
●
At the end of Period 1:
○
MEFA Questionnaire and Adverse Event Reporting
Crossover:
●
Upon completion of Period 1, participants will cross-over to either the Study Product,
THC-Only Product, or Placebo group for up to 7 days.
Period 2: Up to 7 days
●
After 3 product use sessions:
○
Daily survey questions regarding motivation, level of energy, focus and appetite
●
At the end of the Period 2:
○
MEFA Questionnaire and Adverse Event Reporting
Crossover:
●
Upon completion of Period 2, participants will cross-over to either the Study Product,
THC-Only Product, or Placebo group for up to 7 days.
Period 3: Up to 7 days
●
After 3 product use sessions:
○
Daily survey questions regarding motivation, level of energy, focus and appetite
●
At the end of the Period 2:
○
MEFA Questionnaire and Adverse Event Reporting
End of Study:
●
Experience Survey
●
Adverse Event Reporting
7.0 DATA COLLECTION AND MANAGEMENT
7.1 Data Collection Elements, Source, And Method Of Collection
For recruitment purposes only, a data set limited to name, email, telephone number, and Study
ID number will be generated manually. For analysis, data from the assessments will include the
Study ID number and demographic factors (age, gender, race, ethnicity), medications, and
supplements.
7.2 Data Management
Research Data Capture System
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This project will be utilizing People Science’s proprietary platform, Chloe. All data is securely
stored on People Science Amazon Web Services HIPAA compliant servers. The platform
contains modules for building and managing forms / surveys, landing pages, marketing outreach
with tracking tools for recruitment, audited electronic consent forms, data management and
analytics using an integrated relational database.
Data from completed assessments will
automatically be collected for analysis. Study monitoring can be done using reporting features.
7.3 Data Management at Study Completion
For longer term storage of the data that will reduce risk of a data breach while still permitting that
the data be verifiable (audited) the dataset will be de-identified - no names, etc., and all dates
turned into time- and coded, and the key to the code will be housed in a separate location. The
data will be maintained under password protection in the database.
8.0 CODING OF DATA
The dataset for recruitment (name, telephone number and Study ID number) and the data listed
in Section 7.1 for analysis will be stored on a password secured database with access only to
designated study team members and the study investigator.
9.0 STATISTICAL CONSIDERATIONS.
9.1 Sample Size Estimation and Justification
We anticipate screening up to 100 individuals to achieve a final sample size of approximately
50 evaluable participants. To measure our primary outcome, a single question 10-point visual
analogue rating scale (VAS) will be used to reflect motivation after consumption of the Study
Product, THC-Only Product, or Placebo. . The average difference in VAS responses between
these 3 groups will be measured and analyzed.
Up to 20 post-product use questions, and up to 15 daily survey questions will be collected to
reflect any changes in motivation, level of energy, focus, and appetite during the study period. The
average difference in responses between Study Product, THC-Only Product, and Placebo will be
measured and analyzed as secondary outcomes.
9.2 Projected Study Timeline - Accrual, Data/Sample Collection,
Completion
The total sample size for this observational study will be approximately 58 participants.
We anticipate enrollment to be complete in 4 months. Data analysis will be complete in 2
months, and a CSR and lay summary will be complete in another 1 month. Altogether, the study
duration is estimated to be 7 months.
The final analysis will take place after approximately 50 evaluable participants have completed
all final study assessments (i.e. product use sessions, questionnaires, surveys). These activities
will be completed approximately seven weeks after enrollees initiate participation in the study.
9.3 Evaluable Participants
Participants will be considered evaluable for analysis if they complete all assessments in at least
two product use sessions within each group of the study.
9.4 Covariates and Subgroups
Demographic and baseline values will be collected and analyzed on all participants. Data on
age, sex, race/ethnicity, medical history including prior cannabis use, medical diagnoses,
prescriptions, alcohol use, smartphone operating system (Android or iOS) will all be collected
and included in univariate,
bivariate, and multivariate analyses. Subgroup analyses will be
11

conducted to examine differences in outcome by all covariates available.
9.5 Missing Data
Missing data will be imputed with a value of “999”. The proportion of missingness will be
evaluated among all covariates and outcome variables. If data are missing on a variable in under
5% of cases and the assumption of missing completely at random can reasonably be made, only
observed data will be used in the analysis. If a variable is missing within a range of 5%-40% of
cases, use of multiple imputation will be evaluated.
Regression analyses will be conducted
using only complete cases.
9.6 Statistical Analysis Plan
The primary objective of this study is to determine the impact of Phylos’ study product on
motivation as measured by the change in VAS scores from approximately 50 participants.
Univariate statistics will be generated to describe the distribution of patient characteristics and
outcome data. Continuous variables will be described using means, standard deviations,
minimums and maximums while categorical variables will be described using counts and
percentages. VAS scores will be compared from baseline pre-product use; and at end of study
(post-product use) of the same individuals. We will analyze up to 58 participants to achieve at
least 90% power to detect a mean change in VAS scores of 1 point (SD=2) from baseline with a
type I error of 0.05 (two-sided) assuming a paired means dependent Wilcoxon Signed-Rank test.
We are testing the null hypothesis that there is no difference between pre-product use and
post-product use mean VAS scores within study participants. Summary statistics will be
generated, and paired differences between pre-product use and post-product use VAS scores
will be reported, along with 95% confidence intervals.
Additionally, parametric linear mixed models will be employed to simultaneously account for
correlated observations and adjust for confounding variables (Proc Mixed, SAS). Several
covariance structures, including compound symmetry and unstructured, will be evaluated by
comparing AIC and BIC to identify optimal model fit.
Random slope and intercept will also be
considered in a similar manner. Patient characteristics (i.e. age and sex) will be included in
adjusted models a priori for confounding control. Directed acyclic graphs will be employed to
select other potential confounding variables and identify biases during the model fitting process.
Large differences will be further examined and may help identify where further calibration of
estimation models are needed.
Stratified and interaction analyses will be employed to detect between-subgroup differences in
outcomes. Specifically, we will test the difference in VAS score change between Study Product,
THC-Only Product, and Placebo groups. Testing of these differences will be conducted by
including 2-way product terms between the exposure and covariate of interest in linear mixed
modeling. A significant interaction will be defined by an interaction coefficient with a p-value <
0.05.
9.7 Reporting Conventions
Confidence intervals and p-values will be reported at two decimal places, except when p-values
are less than 0.01. P-values less than 0.01 will be reported as “< 0.01” and p-values less than
0.001 will be reported as “<0.001”.
9.8 Quality Assurance of Statistical Programing
SAS 9.4 will be used for all data analyses in a Microsoft Windows environment. All analysis code
will include the author’s name, date/time of writing, reference to location and nature of inputs,
reference to any parent code, and detailed comments to aid in its interpretation and
implementation. A secondary statistician will have access to raw data and the opportunity to
12

independently create the main analyses. They will also be given access to the primary code to
review its validity.
10.0 STUDY COMPLIANCE AND REPORTING OF DEVIATIONS FROM APPROVED
PROCEDURES
Deviations
A deviation is a divergence from a specific element of a protocol and that occurred without
prior IRB approval. Deviations from the approved protocol should be avoided, except when
necessary to eliminate an immediate hazard to a research participant. All deviations from the
protocol will be documented in study source documents and promptly reported to the IRB.
Reporting Deviations
Investigators may deviate from the protocol to eliminate immediate hazards for the protection,
safety, and well-being of the study subjects without prior IRB approval. For any such deviation,
the PI will notify the IRB, within 5 calendar days of its occurrence by electronic submission of a
deviation notice.
11.0 STUDY OVERSIGHT, QUALITY ASSURANCE, AND DATA & SAFETY
MONITORING
The study team will be familiar with anticipated and unanticipated adverse experiences. The
Principal Investigator (PI) is responsible for monitoring protocol conduct and reporting to the
Institutional Review Board (IRB).
12.0 ETHICAL AND REGULATORY CONSIDERATIONS
12.1 Ethical and Regulatory Standard
Ethical Standard
This study will be conducted in conformance with the principles set forth in The Belmont Report:
Ethical Principles and Guidelines for the Protection of Human Subjects of
Research (US
National Commission for the Protection of Human Subjects of Biomedical
and Behavioral
Research, April 18, 1979) and the Declaration of Helsinki.
Regulatory Standard
This study is to be conducted in compliance with the IRB approved protocol and according to
applicable federal, state, local and tribal laws including the following:
●US Code of Federal Regulations (CFR) governing clinical study conduct: Title 45 Part 46 –
Protection of Human Subjects
●
US
Code
of
Federal
Regulations
relating
to
the
Health Insurance Portability and
Accountability Act of 1996: Title 45 Part 164 – Security and Privacy – Subpart E - ○Subpart
E—Privacy of Individually Identifiable Health Information
●State of California Health and Safety Code, Title 17, for research conducted in California
In addition, this study is to be conducted in compliance with applicable policies and procedures
of the IRB(s) of record, applicable institutional research policies and
procedures, applicable
institutional clinical policies and procedures, and applicable NIH policies and procedures.
Institutional Review Board
The protocol, informed consent form(s), recruitment materials and all participant materials will
be submitted to the IRB of record for review and approval. Approval of both the protocol and
the consent form must be obtained before any participant is enrolled. Any amendments to the
protocol or consent materials will require review and approval by the IRB before the changes
13

are implemented in the study.
Per the federal regulations at 45 CFR 46 and State of California Health and Safety code, Title
17, must review and approve this protocol and the informed consent process
and its
documents prior to initiation of the study. All institutional, NIH, Federal, and State of California
regulations must be fulfilled.
Any documents that the IRB may need to fulfill its responsibilities (such as protocol, protocol
amendments, consent forms, information concerning participant recruitment,
payment or
compensation procedures, or other pertinent information) will be submitted
to the IRB. The
IRB’s written unconditional approval of the study protocol and the informed consent document
will be in the possession of the investigator before the study is initiated.
Any amendment to the protocol document and accompanying informed consent documents,
as developed and provided by the PI, will require review and approval by the IRB of record
before the changes are implemented in the study.
12.2 Risk Benefit Considerations
Discomforts, Risks, and Risk Mitigation
●Risks associated with the Survey: The questions used in this survey may cause
temporary discomfort or distress to the participant. The survey is designed to be simple
and short and is a commonly used tool in clinical studies. The participant may choose
not to complete the questionnaire.
●
Risks associated with Breach of Confidentiality: There is minimal risk that people who
are not connected with this study will learn of the participant’s identity or personal
information. The study staff will be GCP trained and will utilize best practices when using
the data platform to ensure participant privacy protections.
Risk Level Determination
The risks to the study are minimal or unanticipated due to appropriate mitigation measures
(e.g. breach of confidentiality, loss of internet access). This research meets the federally
defined definition of minimal risk (45CFR 46.102(j)).
Direct benefit to research participants
Research participants have the opportunity to engage with scientists in tracking the effect
THCV may have on their motivation, energy level, focus, and appetite. Participants will
receive $50 upon completion of study activities.
Importance of the knowledge that may reasonably be expected
This research is significant and important because increasing knowledge and experience in
using a personal device with the ability to connect with health providers virtually may ultimately
change the delivery of healthcare.
12.3 Participant Characteristics
Research equity
This research has no direct exclusions related to gender. There are also no direct exclusions
related to race or ethnicity.
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Vulnerable Populations
Pregnancy and lactation are exclusions due to the unknown risks of cannabis product use to fetuses and
newborns.
Volunteers with impaired decision-making capacity are excluded.
Volunteers unable to personally provide informed consent (including but not exclusive of
inability to speak and read English, hearing or sight impaired, etc.) will be excluded from
participating in this research.
12.4 Financial Obligation, Burden, and Compensation to Participants
Completing research activities (not from results/findings or injury)
Research activities will be conducted virtually.
Participants will receive compensation for their time. A $50 gift card will be provided by study
staff to participants upon study completion.
Research results or clinical findings arising from research activities
Due to the nature of the study, it is unlikely that research results or findings from research
activities will result in further medical-related expenses for the participant.
12.5 Confidentiality/Sharing/Publication
Return or Clinical Use of Research Results
Participants will be shown their study data in real time as they go through the data visualization
modules in the Chloe platform.
Research results will be shared with participants at completion of data analysis. The results of
this research may help the participant make decisions in future product purchases and
participate in future research studies.
There are no anticipated burdens or financial obligations to research subjects.
Confidentiality
All documents and electronic data will be stored on secure, password-protected computers or
cloud-based servers. Participant confidentiality will be strictly held in trust by the investigators,
study personnel, and sponsor. No identifiers will be used in any subsequent publication of these
results.
Information/Data Retention, Future Use, and Sharing
All personal information provided by participants is the property of such participants and a copy
of such information will be shared with People Science. The Study Sponsor will have access to
de-identified data.
Participants have the right to request that their account and associated
personal information be deleted. A participant's information will remain with People Science as
long as the participant is active in the study and/or has an active account and has not requested
that his or her account be deactivated and his/her information be deleted.
Publication
The publication or presentation of any study results shall comply with all applicable privacy laws,
including, but not limited to, the Health Insurance Portability and Accountability Act of 1996.
Neither the complete nor any part of the results of the study carried out under this protocol, nor
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any of the information provided by the sponsor for the purposes of performing the study, will be
published or passed on to any third party without the written approval of the Study PI. Any
investigator involved with this study is obligated to provide the sponsor with all data derived from
the study.
12.6 Alternatives to Participation, Withdrawal, and Early Termination
Alternatives to Participation
The individual can choose not to participate.
Participant Withdrawal from Research/ Research Activities
Research activities are limited to approximately seven weeks.
Participants may withdraw from the study at any time and for any reason without prejudice. The
withdrawal must be documented.
12.7 Informed Consent, HIPAA Authorization, and California Subject’s Bill of
Rights
Informed Consent
Informed consent is a process that is initiated prior to the individual agreeing to participate in the
study
and
continues
throughout study participation. Operational details specific to the
consenting process that occurs prior to any research evaluations/interventions are described in
Section 6.0.
All participants will undergo virtual electronic informed consent after they are determined to
qualify for the study. An electronic informed consent document will describe the nature, duration,
purpose of the study, potential risks, alternatives and potential benefits, and all other IRB
approved information. In addition, the experimental participant’s bill of rights and the HIPAA
research authorization form will be provided. Prospective research participants will be informed
that they may withdraw from the study at any time and for any reason without prejudice.
Prospective research participants will be afforded sufficient time to consider whether to
participate in the research.
Virtual informed consent will be conducted through the app-based consent form at the
participant’s convenience. After reading the consent, participants will be able to contact study
staff about any study related questions. Once the prospective participant expresses full
understanding, virtual informed consent will be obtained through electronic signature from either
the prospective participant before study participation. The method of obtaining and documenting
the informed consent and the contents of the consent must comply with the ICH-GCP and all
applicable regulatory requirements. A copy of the signed consent document will be available to
the participant within the Chloe app. The signed consent must be maintained by the investigator
and available for inspection by sponsor designated representatives, or regulatory authority at
any time.
Privacy Authorization
The informed consent process will include a privacy authorization compliant with
45CFR164.508(c) via the inclusion/incorporation of:
-
all core elements specified in 508(c)(1) including the signature of the individual (or
representative) and date of signature,
-
all required statements specified in 508(c)(2)
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-
the plain language requirement as specified in 508(c)(3), and
-
the provision to the participant (or representative) a copy of the signed authorization
(508(c)(4)
State of California Human Experimentation Requirements
This research involves the collection of information via validated questionnaires and obtaining
information from the medical record. Research activities do not encompass those that are
requisite for a participant to be involved in a “medical experiment” as defined by California State
Law 24174. The ‘California Experimental Subject’s Bill of Rights’ will be administered as part of
the informed consent process; as part of that process participants will receive a copy of the ‘Bill
of Rights’ marked with their signature.
12.8 Investigator Conflict of Interest
Investigators will disclose any conflict of interest from People Science.
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or
financial gain greater than the minimum allowable by their institution, etc.) must have the conflict
reviewed by a properly constituted Conflict of Interest Committee with a Committee-sanctioned
conflict management plan that has been reviewed and approved by the study Sponsor prior to
participation in this study. All investigators will follow the conflict of interest policy.
13.0 REFERENCES
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Bolognini, D., Costa, B., Maione, S., Comelli, F., Marini, P., Di Marzo, V., Parolaro, D., Ross, R.A.,
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Wargent ET, Zaibi MS, Silvestri C, Hislop DC, Stocker CJ, Stott CG, Guy GW, Duncan M, Di
Marzo V, Cawthorne MA. The cannabinoid Δ(9)-tetrahydrocannabivarin (THCV) ameliorates
insulin sensitivity in two mouse models of obesity. Nutr Diabetes. 2013 May 27;3(5):e68. doi:
10.1038/nutd.2013.9. PMID: 23712280; PMCID: PMC3671751.
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Jadoon KA, Ratcliffe SH, Barrett DA, Thomas EL, Stott C, Bell JD, O'Sullivan SE, Tan GD.
Efficacy
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Tetrahydrocannabivarin
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Glycemic
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Parameters in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled,
Parallel Group Pilot Study. Diabetes Care. 2016 Oct;39(10):1777-86. doi: 10.2337/dc16-0650.
Epub 2016 Aug 29. PMID: 27573936.
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