Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04577612
Other study ID # USA710-4010
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 1, 2020
Est. completion date May 25, 2021

Study information

Verified date June 2021
Source Canopy Growth Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date May 25, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CHI-554
hemp-derived CBD in MCT oil

Locations

Country Name City State
United States Ellen W Leen-Feldner, University of Arkansas Fayetteville Arkansas

Sponsors (2)

Lead Sponsor Collaborator
Canopy Growth Corporation University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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). 1 day
Other 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). 1 day
Other 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. 1 day
Other 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. 1 day
Primary 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 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. 1 day
Secondary 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. 1 day
Secondary AUC in state anxiety ratings AUC-I in state anxiety ratings (VAS) across the experimental period as calculated using the trapezoidal formula. 1 day
Secondary Mean intensity using DSQ mean intensity of physical attack symptoms, cognitive panic attack symptoms, and percentage of participants endorsing a panic attack. 1 day
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A