AnxietyPhase 2NCT04269252
CHI-907 CBD Extract and Experiences of Test Anxiety
A Phase 2 study testing CHI-907 and CHI-804 in people with Anxiety, run by Canopy Growth Corporation at 1 site in United States.
Trial summary
This is a randomized, placebo-controlled study examining the effects of CHI-907 on test anxiety specifically, and state anxiety more broadly. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- CHI-907 and CHI-804
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 1 Jun 2021
- Phase
- Phase 2
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
James Madison University
Harrisonburg, Virginia, 22807
About this study
Official title: A Randomized Controlled Test of the Effects of CHI-907 on Experiences of Test Anxiety Among College Students
This is a randomized, placebo-controlled study examining the effects of CHI-907 on test anxiety specifically, and state anxiety more broadly.
- Conditions
- Anxiety
- Being tested
- CHI-907, CHI-804
- Keywords
- Anxiety, Test Anxiety, CBD
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHI-907Other
CHI-907 is a high CBD extract.
CHI-804Other
CHI-804 is the placebo formulation.
| Study group | Role | What they receive |
|---|---|---|
| CHI-804 at 6 mL | Placebo comparator | Standard 6 mL dose of placebo oil. Receives: Other: CHI-804 |
| CHI-907 at 1.5 mL | Active comparator | Subjects are assigned to receive one dose of CHI-907. Receives: Other: CHI-907 |
| CHI-907 at 3 mL | Active comparator | Subjects are assigned to receive one dose of CHI-907. Receives: Other: CHI-907 |
| CHI-907 at 6 mL | Active comparator | Subjects are assigned to receive one dose of CHI-907. Receives: Other: CHI-907 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: The test session visit is 3.5 hours long.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start3 Feb 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Why it stopped: Recruitment challenges due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canopy Growth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- James Madison University
- Responsible party
- Sponsor
- Investigators
- Mark Ware, MD, Study director, Canopy Growth Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269252
- Sponsor's protocol ID
- USA710-4003
- Status last verified
- Jun 2021
- First submitted
- 7 Feb 2020
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Test of the Effects of CHI-907 on Experiences of Test Anxiety Among College Students
- ClinicalTrials.gov ID
- NCT04269252
- Acronym / sponsor ID
- USA710-4003
- Conditions
- Anxiety
- Keywords
- Anxiety, Test Anxiety, CBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges due to COVID
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Canopy Growth CorporationIndustry (pharma, biotech, devices)
- Collaborators
- James Madison University
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 13 Feb 2020 (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.
This is a randomized, placebo-controlled study examining the effects of CHI-907 on test anxiety specifically, and state anxiety more broadly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CHI-804 at 6 mL | Placebo comparator | Other: CHI-804Standard 6 mL dose of placebo oil. |
| CHI-907 at 1.5 mL | Active comparator | Other: CHI-907Subjects are assigned to receive one dose of CHI-907. |
| CHI-907 at 3 mL | Active comparator | Other: CHI-907Subjects are assigned to receive one dose of CHI-907. |
| CHI-907 at 6 mL | Active comparator | Other: CHI-907Subjects are assigned to receive one dose of CHI-907. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| CHI-907CHI-907 is a high CBD extract. | Other | CHI-907 at 1.5 mL, CHI-907 at 3 mL, CHI-907 at 6 mL |
| CHI-804CHI-804 is the placebo formulation. | Other | CHI-804 at 6 mL |
Primary outcome
Optimal single-dose of CHI-907 to reduce test anxiety
Time frame: The test session visit is 3.5 hours long.
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).
Minimal single-dose of CHI-907 to reduce test anxiety
Time frame: The test session visit is 3.5 hours long.
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).
Results and safety
The study was stopped early (reason given: Recruitment challenges due to COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Mark Ware, MD study director
Canopy Growth Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHI-907 and CHI-804 in people with Anxiety, run by Canopy Growth Corporation 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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 4 Jun 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment challenges due to COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal single-dose of CHI-907 to reduce test anxiety (time frame: The test session visit is 3.5 hours long.). The study lists 2 primary outcomes in all. 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 4 Jun 2021.