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A Randomized Controlled Test of the Effects of CHI-554 on Fear. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized Controlled Test of the Effects of CHI-554 on Fear (F-01)

NCT04577612•Canopy Growth Corporation

Summary

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

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.

Eligibility

Age

18 - 55 years

Sex

ALL

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

•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.
+9 more criteria

Locations (1)

Ellen W Leen-Feldner, University of Arkansas

Fayetteville, Arkansas, United States

Key Dates

Start Date

September 1, 2020

Primary Completion Date

May 15, 2021

Completion Date

May 25, 2021

Last Updated

June 3, 2021

Enrollment

ACTUAL participants

Conditions

AnxietyFearPanic

Interventions

CHI-554

DRUG

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RuminationWorry+4 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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