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

NCT04577612 | Completed Phase 2

• 1 other identifier: USA710-4010
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety; Fear; Panic

Outcome Measures

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).

  1 day

Secondary Outcomes (4)

• AUC in mean fear ratings

  1 day

• Self-reported anxiety

  1 day

• AUC in state anxiety ratings

  1 day

• Mean intensity using DSQ

  1 day

Other Outcomes (4)

• mean mid-challenge fear ratings

  1 day

• mean mid-challenge heart rate

  1 day

• AUC in mean heart rate

  1 day

Study Arms (4)

Group 1

EXPERIMENTAL

150 mg CBD

Drug: CHI-554

Group 2

EXPERIMENTAL

300 mg CBD

Drug: CHI-554

Group 3

EXPERIMENTAL

600 mg CBD

Drug: CHI-554

Group 4

PLACEBO COMPARATOR

Placebo MCT oil

Drug: CHI-554

Interventions

CHI-554 DRUG

hemp-derived CBD in MCT oil

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

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

You may qualify if:

• Person is between 18 and 55-years-old (inclusive).
• Person has a BMI between 18 and 35 kg/m2 (inclusive).
• Person is willing and able to provide informed consent and attend a 3.5-hour, in-person session.
• Woman of childbearing potential must not be pregnant or currently breastfeeding.
• 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.
• Person agrees to abide by all study restrictions and comply with all study procedures.

You may not qualify if:

• 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.
• 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).
• 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.
• 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).
• 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);
• Person has a positive drug screen for THC, barbiturates, amphetamines, benzodiazepines, and/or opiates at baseline assessment.
• Person meets diagnostic criteria for a current DSM-5 diagnosis indexed via the MINI.
• Person meets criteria for a lifetime history of an unexpected or unprovoked panic attack indexed via the MINI.
• Person endorses current suicidal intent as indexed via the C-SSRS.
• 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.
• Person has participated in a study that used a CO2-enriched air procedure.
• Person has received formal training to tolerate elevated levels of CO2 or bodily arousal (such as free diver training or interoceptive exposure-based treatment).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Canopy Growth Corporation: lead
• University of Arkansas: collaborator

Study Sites (1)

Ellen W Leen-Feldner, University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study. Investigators, study personnel, and participants will be blinded to the group assignment during the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2b, randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: September 1, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 25, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-06

Locations

US (1)