CHI-907 CBD Extract and Experiences of Test Anxiety

Study Overview
=================
Brief Summary
-----------------
This is a randomized, placebo-controlled study examining the effects of CHI-907 on test anxiety specifically, and state anxiety more broadly.

Official Title
-----------------
A Randomized Controlled Test of the Effects of CHI-907 on Experiences of Test Anxiety Among College Students

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Other: CHI-907
* Other: CHI-804


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult between 18 and 55-years-old (inclusive). Willing and able to provide informed consent and attend a 2.5 hour, in-person session. Self-reports completing a college-level introductory level statistics class with a grade of C or better. Scores a 3.0 or higher on the Westside Test Anxiety Scale. Female of childbearing potential must not be pregnant or currently breastfeeding. If using medication, the student has maintained a stable regimen on existing medications for at least one month prior to participation in the study and throughout the study. Agrees to abide by all study restrictions and comply with all study procedures. Exclusion Criteria: Known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, or excipients of the investigational product. Exposed to any investigational drug or device < 30 days prior to screening or plans to take an investigational drug in the near future. Used cannabis, synthetic cannabinoid or cannabinoid analogue, synthetic cannabinoid receptor agonist, or any CBD- or THC-containing product within 30 days of screening or during the study. Current or past primary DSM-5 diagnosis other than an anxiety disorder that the Investigator determines would interfere in testing or interfere in evaluation of the study testing. Total score of 8 or higher on the Alcohol Use Disorders Identification Test. Total score of 12 or higher on the Drug Abuse Screening Test. An acute or progressive disease that is likely to require changes in drug therapy during the study, or interfere with the objectives of the study, or the ability to adhere to protocol requirements. Currently prescribed medications with likely THC- or CBD- interactions. History of suicide attempt in the last year. Endorses current suicidal intent during the baseline assessment. Positive drug screen for THC, barbiturates, amphetamines, benzodiazepines, and/or opiates at baseline assessment. Clinically significant condition or abnormal findings during screening or the baseline assessment that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study testing. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol. Female student of childbearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter. Male student whose partner is of childbearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter. Any other significant disease or disorder which, in the opinion of the investigator, may either put the student at risk because of participation in the study, may influence the result of the study, or affect the student's ability to participate in the study. History of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase [ALT] >5 ´ upper limit of normal [ULN] or total bilirubin [TBL] >2 ´ ULN) OR the ALT or aspartate aminotransferase (AST) >3 ´ ULN and TBL >2 ´ ULN (or international normalized ratio [INR] >1.5). Plans for the student to travel outside their country of residence during the study. Body mass index (BMI) of underweight (18 kg/m2 and below) or obese (30 kg/m2 and above) or waist:hip ratio that is considered high health risk (0.86 and higher for women, 1.0 and higher for men).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CHI-804 at 6 mL<br>Standard 6 mL dose of placebo oil. | Other: CHI-804<br>* CHI-804 is the placebo formulation.<br>|
| Active Comparator: CHI-907 at 1.5 mL<br>Subjects are assigned to receive one dose of CHI-907. | Other: CHI-907<br>* CHI-907 is a high CBD extract.<br>|
| Active Comparator: CHI-907 at 3 mL<br>Subjects are assigned to receive one dose of CHI-907. | Other: CHI-907<br>* CHI-907 is a high CBD extract.<br>|
| Active Comparator: CHI-907 at 6 mL<br>Subjects are assigned to receive one dose of CHI-907. | Other: CHI-907<br>* CHI-907 is a high CBD extract.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal single-dose of CHI-907 to reduce test anxiety | Subjects will report their level of test anxiety using the State Test Anxiety Visual Analog Scale (STAI-VAS) pre-test, mid-test, and post-test. The STAI-VAS is a measure from 0 (not anxious at all) to 100 (anxious). | The test session visit is 3.5 hours long. | 
| Minimal single-dose of CHI-907 to reduce test anxiety | Subjects will report their level of test anxiety using the State Test Anxiety Visual Analog Scale (STAI-VAS) pre-test, mid-test, and post-test. The STAI-VAS is a measure from 0 (not anxious at all) to 100 (anxious). | The test session visit is 3.5 hours long. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CBD, Anxiety, Test Anxiety