Impact of CBD-Rich Oil on Aversive Memory Reconsolidation
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| ClinicalTrials.gov Identifier: NCT04726475 |
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Recruitment Status :
Recruiting
First Posted : January 27, 2021
Last Update Posted : January 19, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety and Fear | Behavioral: Interoceptive Aversive Memory Reactivation Dietary Supplement: Cannabidiol (CBD)-Rich Broad Spectrum Hemp Extract Oil Dietary Supplement: Placebo Oil | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 96 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of Cannabidiol-Rich Hemp Extract Oil on Reconsolidation Disruption of Naturalistic Interoceptive Aversive Memory in Humans |
| Estimated Study Start Date : | January 2022 |
| Estimated Primary Completion Date : | January 2024 |
| Estimated Study Completion Date : | January 2024 |
| Arm | Intervention/treatment |
|---|---|
Experimental: CBD-WR
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Behavioral: Interoceptive Aversive Memory Reactivation
In order to reactivate interoceptive aversive memory, participants will be asked to breathe a medical grade 35% CO2/65% O2 gas mixture which produces somatic perturbations. The 35% CO2 challenge is a widely used and safe symptom induction technique that has been utilized in our laboratory in several experiments. Participants will be informed that breathing the gas is safe, but that it will likely cause changes in their physical sensations. Participants will specifically be asked to breathe the gas mixture normally with their mouth open through an oxygen mask for 10 seconds. Dietary Supplement: Cannabidiol (CBD)-Rich Broad Spectrum Hemp Extract Oil 300mg CBD-rich hemp-derived formulation in MCT coconut oil. |
Placebo Comparator: PBO-WR
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Behavioral: Interoceptive Aversive Memory Reactivation
In order to reactivate interoceptive aversive memory, participants will be asked to breathe a medical grade 35% CO2/65% O2 gas mixture which produces somatic perturbations. The 35% CO2 challenge is a widely used and safe symptom induction technique that has been utilized in our laboratory in several experiments. Participants will be informed that breathing the gas is safe, but that it will likely cause changes in their physical sensations. Participants will specifically be asked to breathe the gas mixture normally with their mouth open through an oxygen mask for 10 seconds. Dietary Supplement: Placebo Oil 3ml oral dose of MCT coconut oil. |
Active Comparator: CBD-OR
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Behavioral: Interoceptive Aversive Memory Reactivation
In order to reactivate interoceptive aversive memory, participants will be asked to breathe a medical grade 35% CO2/65% O2 gas mixture which produces somatic perturbations. The 35% CO2 challenge is a widely used and safe symptom induction technique that has been utilized in our laboratory in several experiments. Participants will be informed that breathing the gas is safe, but that it will likely cause changes in their physical sensations. Participants will specifically be asked to breathe the gas mixture normally with their mouth open through an oxygen mask for 10 seconds. Dietary Supplement: Cannabidiol (CBD)-Rich Broad Spectrum Hemp Extract Oil 300mg CBD-rich hemp-derived formulation in MCT coconut oil. |
- CO2 Emotional Reactivity [ Time Frame: 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).
- CO2 Emotional Distress Recovery Trajectory [ Time Frame: 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) [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria include:
- Ages 18-65
- Fluent in English
- Willingness to refrain from all non-study cannabis use during the study period.
Exclusion criteria include:
- Insufficient phobicity (<50 on CO2 challenge);
- Presence of significant suicidality;
- History of psychosis;
- Currently receiving exposure-based treatment;
- Current substance use disorder;
- Unstable psychiatric medication for a psychological condition;
- Medical conditions contraindicating CO2 inhalation (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke);
- Any medical problems (e.g., liver or renal abnormalities) or medication use that would preclude ingesting CBD oil, including but not limited to currently taking blood thinners (e.g., Warfarin and some anti-epileptic medications);
- History of an adverse reaction to CBD oil or other CBD products,
- Coconut allergy (coconut oil is the carrier oil for CBD-rich extract)
(l) Regular cannabis use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726475
| Contact: Michael J. Telch, PhD | 5125604100 | telch@austin.utexas.edu | |
| Contact: Eric D. Zaizar, B.A. | 8303704044 | eric.zaizar@utexas.edu |
| United States, Texas | |
| University of Texas | Recruiting |
| Austin, Texas, United States, 78712 | |
| Contact: Michael J. Telch, PhD 512-560-4100 telch@austin.utexas.edu | |
| Contact: Eric D Zaizar, B.A. 8303704044 eric.zaizar@utexas.edu | |
| Principal Investigator: | Michael J. Telch, PhD | University of Texas at Austin |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Texas at Austin |
| ClinicalTrials.gov Identifier: | NCT04726475 |
| Other Study ID Numbers: |
2020-07-0141 |
| First Posted: | January 27, 2021 Key Record Dates |
| Last Update Posted: | January 19, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cannabidiol Anticonvulsants |