Impact of CBD-Rich Oil on Aversive Memory Reconsolidation

Phase 1

• Conditions: Anxiety and Fear

• Registration Number: NCT04726475
• Lead Sponsor: University of Texas at Austin

Brief Summary

The purpose of this study is to test whether cannabidiol (CBD) rich hemp extract oil can interfere with the reconsolidation (storage) of pathological fear memory in humans.

Detailed Description

Preclinical experiments demonstrate that isolated cannabidiol (CBD), the non-psychotomimetic constituent of the Cannabis sativa plant, disrupts reconsolidation of aversive memories conditioned in the laboratory when administered within the memory reconsolidation window (\< 6 hrs. post-retrieval) by indirectly activating cannabinoid type-1 (CB1) receptors in the dorsal anterior cingulate cortex (dACC). Furthermore, background material (e.g., terpenoids) naturally present in the cannabis plant may also disrupt aversive memory reconsolidation both alone and in concert with CBD. Based on these preclinical findings, we aim to test whether administration of 300mg CBD-rich hemp extract oil following fear reactivation of an aversive interoceptive threat memory can disrupt reconsolidation of naturalistic aversive memories in humans. More specifically, naturalistic interoceptive aversive memories, a form of transdiagnostic fear memory that contributes to the pathogenesis of fear-related disorders such as panic disorder, posttraumatic stress disorder (PTSD), and illness anxiety disorder.

For this proof-of-concept double-blind trial, volunteers (n=96) reporting elevated fears of somatic sensations will be stratified on biological sex and baseline levels of interoceptive fear and randomized to one of three intervention arms: (a). CBD-rich oil administered within the reconsolidation window, (b). Placebo oil administered within the reconsolidation window, or (c). CBD-rich oil administered outside of the reconsolidation window. Change in emotional reactivity to a 35% CO2 challenge from baseline to two-week follow-up will serve as our primary outcome.

Study findings may contribute towards the development of a novel ultra-brief transdiagnostic intervention guided by reconsolidation theory for individuals prone to fear-related psychiatric disorders.

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-27
• Status Verified: 2022-01
• Study Start: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-19
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CO2 Emotional Reactivity	Two-week follow-up	Self-reported peak-distress (range: 0-100), defined as the highest level of distress experienced at any point during the 35% CO2 challenge completed at the two-week follow-up assessment, adjusting for baseline rating (immediately after the 35% CO2 challenge, but before receiving either immediate CBD/placebo or delayed CBD).

Secondary Outcome Measures

Name	Time	Method
CO2 Emotional Distress Recovery Trajectory	Two-week follow-up	Participants will be asked to rate their current distress level (range: 0-100) every minute for five consecutive minutes after the CO2 inhalation (recovery phase). Change in CO2 emotional distress recovery trajectory from baseline to the two-week follow will serve as a secondary continuous index of emotional reactivity to somatic cues.
Short Scale Anxiety Sensitivity Index (SASSI)	Two-week	The 5-item SSASI is a self-report instrument designed to measure the transdiagnostic construct of anxiety sensitivity, defined as a fear of anxiety and arousal-related sensations. Change on the SSASI from baseline to the two-week follow-up will serve as a secondary outcome measure.

Trial Locations

Locations (1)

University of Texas; 🇺🇸 Austin, Texas, United States