CHI-907 CBD Extract and Experiences of Test Anxiety

NCT ID: NCT04269252

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2021-06-01

Brief Summary

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

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

CHI-804 at 6 mL

Standard 6 mL dose of placebo oil.

Group Type: PLACEBO_COMPARATOR

CHI-804

Intervention Type: OTHER

CHI-804 is the placebo formulation.

CHI-907 at 1.5 mL

Subjects are assigned to receive one dose of CHI-907.

Group Type: ACTIVE_COMPARATOR

CHI-907

Intervention Type: OTHER

CHI-907 is a high CBD extract.

CHI-907 at 3 mL

Subjects are assigned to receive one dose of CHI-907.

Group Type: ACTIVE_COMPARATOR

CHI-907

Intervention Type: OTHER

CHI-907 is a high CBD extract.

CHI-907 at 6 mL

Subjects are assigned to receive one dose of CHI-907.

Group Type: ACTIVE_COMPARATOR

CHI-907

Intervention Type: OTHER

CHI-907 is a high CBD extract.

Interventions

CHI-907

CHI-907 is a high CBD extract.

Intervention Type: OTHER

CHI-804

CHI-804 is the placebo formulation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy adult between 18 and 55-years-old (inclusive).

2. Willing and able to provide informed consent and attend a 2.5 hour, in-person session.

3. Self-reports completing a college-level introductory level statistics class with a grade of "C" or better.

4. Scores a 3.0 or higher on the Westside Test Anxiety Scale.

5. Female of childbearing potential must not be pregnant or currently breastfeeding.

6. 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.

7. Agrees to abide by all study restrictions and comply with all study procedures.

Exclusion Criteria

1. Known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, or excipients of the investigational product.

2. Exposed to any investigational drug or device < 30 days prior to screening or plans to take an investigational drug in the near future.

3. 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.

4. 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.

5. Total score of 8 or higher on the Alcohol Use Disorders Identification Test.

6. Total score of 12 or higher on the Drug Abuse Screening Test.

7. 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.

8. Currently prescribed medications with likely THC- or CBD- interactions.

9. History of suicide attempt in the last year.

10. Endorses current suicidal intent during the baseline assessment.

11. Positive drug screen for THC, barbiturates, amphetamines, benzodiazepines, and/or opiates at baseline assessment.

12. 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.

13. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.

14. 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.

15. 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.

16. 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.

17. 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).

18. Plans for the student to travel outside their country of residence during the study.

19. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

James Madison University

OTHER

Sponsor Role: collaborator

Canopy Growth Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Ware, MD

Role: STUDY_DIRECTOR

Canopy Growth Corporation

Locations

James Madison University

Harrisonburg, Virginia, United States

Countries

United States

Other Identifiers

USA710-4003

Identifier Type: -

Identifier Source: org_study_id