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CompletedNCT04577612Updated Jun 3, 2021

A Randomized Controlled Test of the Effects of CHI-554 on Fear.

A Phase 2 interventional study of CHI-554 in Anxiety, Fear and Panic, sponsored by Canopy Growth Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-03.

Sponsored by Canopy Growth Corporation · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled phase 2b clinical trial examining the effects of CHI-554 (CBD) on Fear (F-01)

Read the detailed description

This study will examine the potential of a novel formulation of hemp-derived CBD (CHI-554) to reduce fear elicited via a safe, well-established, controlled, laboratory-based carbon dioxide (CO2)-enriched air biological challenge that causes abrupt increases in bodily arousal.

02

Conditions studied

  • Anxiety
  • Fear
  • Panic
03

In context

Lead sponsor

Canopy Growth Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Person is between 18 and 55-years-old (inclusive).
  2. Person has a BMI between 18 and 35 kg/m2 (inclusive).
  3. Person is willing and able to provide informed consent and attend a 3.5-hour, in-person session.
  4. Woman of childbearing potential must not be pregnant or currently breastfeeding.
  5. If person uses medication, the person has maintained a stable dose and regimen on existing medications for at least 30 days prior to participation in the study and throughout the study.
  6. Person agrees to abide by all study restrictions and comply with all study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Person has a known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, hemp products, or excipients of the IP.
  2. Person has been exposed to any investigational drug or device \< 30 days prior to screening or plans to take an investigational drug in the near future (within 30 days).
  3. Person has used cannabis, synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), synthetic cannabinoid receptor agonist (e.g., spice, K2), or any CBD- or delta-9- tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
  4. Person is currently prescribed medications with likely THC- or CBD- interactions (e.g., warfarin, clobazam, valproic acid, phenobarbital, mechanistic target of rapamycin [mTOR] inhibitors, oral tacrolimus, St. John's wort; Epidiolex).
  5. Person is currently prescribed and using a medication used in the treatment of anxiety disorders (e.g., selective serotonin uptake inhibitors, venlafaxine, buspirone, benzodiazepines, hydroxyzine, tiagabine, gabapentin, valproate, lamotrigine, topiramate, beta blockers, clonidine, guanfacine, atypical antipsychotics);
  6. Person has a positive drug screen for THC, barbiturates, amphetamines, benzodiazepines, and/or opiates at baseline assessment.
  7. Person meets diagnostic criteria for a current DSM-5 diagnosis indexed via the MINI.
  8. Person meets criteria for a lifetime history of an unexpected or unprovoked panic attack indexed via the MINI.
  9. Person endorses current suicidal intent as indexed via the C-SSRS.
  10. Person reports a history of being diagnosed with a respiratory or lung disease (including asthma attacks), cardiac or pulmonary disease, epilepsy, narcolepsy, sleep apnea, anemia, or renal disease during a medical history interview.
  11. Person has participated in a study that used a CO2-enriched air procedure.
  12. Person has received formal training to tolerate elevated levels of CO2 or bodily arousal (such as free diver training or interoceptive exposure-based treatment).
  13. Any other clinically significant disease or disorder or abnormal findings during screening or the baseline assessment that, in the opinion of the investigator, may either put the person at risk because of participation in the study, may confound the results of the study, or affect the person's ability to participate in the study.
  14. Person has an acute or progressive disease that is likely to interfere with the objectives of the study, or the ability to adhere to protocol requirements.
  15. Woman of childbearing potential, unless she has not engaged in vaginal intercourse or she has used effective contraception when doing so (for example, oral contraception, double barrier, intra-uterine device) for at least 30 days prior to the study.
  16. Woman of childbearing potential, unless willing to ensure that she or her partner use effective contraception (for example, oral contraception, double barrier, intra-uterine device) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).
  17. Man whose partner is of childbearing potential, unless willing to ensure that he or his partner use effective contraception (for example, oral contraception, double barrier, intra-uterine device) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).
  18. Person has 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).
  19. Person demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Group 1

    150 mg CBD

    Drug: CHI-554

  • Experimental
    Group 2

    300 mg CBD

    Drug: CHI-554

  • Experimental
    Group 3

    600 mg CBD

    Drug: CHI-554

  • Placebo comparator
    Group 4

    Placebo MCT oil

    Drug: CHI-554

Interventions

  • DrugCHI-554

    hemp-derived CBD in MCT oil

06

What researchers measure

Primary outcomes

  1. Fear ratings

    Mean mid-challenge fear ratings measured (via continuous transducer input with a range of 1 to 10, where higher ratings reflect more fear) during seconds 300-330 of the experimental procedure (seconds 150-180 of the biological challenge).

    Time frame: 1 day

Secondary outcomes

  1. AUC in mean fear ratings

    Area under the curve with respect to increase (AUCI) in mean fear ratings (measured via continuous transducer input, with a range of 1 to 10, where higher ratings reflect more fear) sampled at baseline and during 30-second epochs each minute before, during, and after the biological challenge as calculated using the trapezoidal formula.

    Time frame: 1 day

  2. Self-reported anxiety

    Self-reported anxiety (state form of the Spielberger State-Trait Anxiety Inventory (STAI), with a possible range of scores from 20 to80, where higher scores reflect greater anxiety) measured immediately prior to beginning the biological challenge.

    Time frame: 1 day

  3. AUC in state anxiety ratings

    AUC-I in state anxiety ratings (VAS) across the experimental period as calculated using the trapezoidal formula.

    Time frame: 1 day

  4. Mean intensity using DSQ

    mean intensity of physical attack symptoms, cognitive panic attack symptoms, and percentage of participants endorsing a panic attack.

    Time frame: 1 day

Other outcomes

  1. mean mid-challenge fear ratings

    Mean mid-challenge fear ratings (continuous transducer input, with a range of 1 to 10, where higher ratings reflect more fear) during seconds 300-330 of the experimental procedure (seconds 150-180 of the biological challenge) as a function of the interaction between anxiety sensitivity - physical concerns (Physical Concerns sub-scale of the ASI-3) and group (placebo, 150 mg CBD, 300 mg CBD, 600 mg CBD).

    Time frame: 1 day

  2. mean mid-challenge heart rate

    Mean mid-challenge heart rate during seconds 300-330 of the experimental procedure (seconds 150-180 of the biological challenge).

    Time frame: 1 day

  3. AUC in mean heart rate

    AUCI in mean heart rate sampled at baseline and during 30-second epochs each minute before, during, and after the biological challenge as calculated using the trapezoidal formula.

    Time frame: 1 day

  4. AUC in mean blood oxygen level

    AUCI in mean blood oxygen level sampled at baseline and during 30-second epochs each minute before, during, and after the biological challenge as calculated using the trapezoidal formula.

    Time frame: 1 day

07

Study locations

1 site
  • Ellen W Leen-Feldner, University of Arkansas
    Fayetteville, Arkansas 72701, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04577612
Lead sponsor
Canopy Growth Corporation
Collaborators
University of Arkansas
Responsible party
Sponsor
First posted
Oct 8, 2020
Start date
Sep 1, 2020
Primary completion
May 15, 2021
Completion
May 25, 2021
Last update
Jun 3, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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