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
This is a randomized, double-blind, placebo-controlled phase 2b clinical trial examining the effects of CHI-554 (CBD) on Fear (F-01)
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.
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.
Exclusion Criteria:
150 mg CBD
Drug: CHI-554
300 mg CBD
Drug: CHI-554
600 mg CBD
Drug: CHI-554
Placebo MCT oil
Drug: CHI-554
hemp-derived CBD in MCT oil
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
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
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
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
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
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
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
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
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
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Canopy Growth Corporation