CHI-907 CBD Extract and Experiences of Test Anxiety

NCT04269252 | Terminated Phase 2

• 1 other identifier: USA710-4003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Anxiety; Test Anxiety; CBD

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (4)

CHI-804 at 6 mL

PLACEBO COMPARATOR

Standard 6 mL dose of placebo oil.

Other: CHI-804

CHI-907 at 1.5 mL

ACTIVE COMPARATOR

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

Other: CHI-907

CHI-907 at 3 mL

ACTIVE COMPARATOR

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

Other: CHI-907

CHI-907 at 6 mL

ACTIVE COMPARATOR

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

Other: CHI-907

Interventions

CHI-907 OTHER

CHI-907 is a high CBD extract.

CHI-907 at 1.5 mL; CHI-907 at 3 mL; CHI-907 at 6 mL

CHI-804 OTHER

CHI-804 is the placebo formulation.

CHI-804 at 6 mL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canopy Growth Corporation: lead
• James Madison University: collaborator

Study Sites (1)

James Madison University

Harrisonburg, Virginia, 22807, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mark Ware, MD

  Canopy Growth Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 13, 2020
• Study Start: February 3, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)