Impact of CBD-Rich Oil on Aversive Memory Reconsolidation
Impact of Cannabidiol-Rich Hemp Extract Oil on Reconsolidation Disruption of Naturalistic Interoceptive Aversive Memory in Humans
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedJanuary 19, 2022
January 1, 2022
2 years
January 22, 2021
January 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
CO2 Emotional Reactivity
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).
Two-week follow-up
Secondary Outcomes (2)
CO2 Emotional Distress Recovery Trajectory
Two-week follow-up
Short Scale Anxiety Sensitivity Index (SASSI)
Two-week
Study Arms (3)
CBD-WR
EXPERIMENTAL* 300 mg CBD-rich hemp extract oil administered within the reconsolidation window. * The timing of CBD-rich oil administration is based on preclinical studies demonstrating that CBD's disruptive effects on reconsolidation procedurally depend on timing pharmacological administration to be within the memory reconsolidation window (\< 6 hrs. post-retrieval). * Thus, immediately after the 35% CO2 interoceptive memory reactivation procedure and associated measures (see measures), participants will be asked to take a single 300mg CBD-rich oral dose of a hemp-derived oil formulation.
PBO-WR
PLACEBO COMPARATOR* Placebo administered within the reconsolidation window. * Immediately after the 35% CO2 interoceptive memory reactivation procedure and associated measures (see measures), participants will be asked to take a single dose of an MCT coconut oil placebo solution.
CBD-OR
ACTIVE COMPARATOR* CBD-rich hemp extract oil administered outside of the reconsolidation window. * Participants will be asked to take a single 300mg oral dose of CBD-rich oil approximately 24 hrs after the initial 35% CO2 interoceptive memory reactivation challenge. * Thus, CBD will be administered well beyond the critical period for memory reconsolidation. The inclusion of this third arm provides a more robust test of the specific reconsolidation theory-based study hypotheses and aids in controlling for any nonspecific possible anxiolytic effects of CBD.
Interventions
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.
300mg CBD-rich hemp-derived formulation in MCT coconut oil.
Eligibility Criteria
You may qualify if:
- Ages 18-65
- Fluent in English
- Willingness to refrain from all non-study cannabis use during the study period.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas
Austin, Texas, 78712, United States
Related Publications (4)
Stern CAJ, de Carvalho CR, Bertoglio LJ, Takahashi RN. Effects of Cannabinoid Drugs on Aversive or Rewarding Drug-Associated Memory Extinction and Reconsolidation. Neuroscience. 2018 Feb 1;370:62-80. doi: 10.1016/j.neuroscience.2017.07.018. Epub 2017 Jul 17.
PMID: 28729064BACKGROUNDMurkar A, Kent P, Cayer C, James J, Durst T, Merali Z. Cannabidiol and the Remainder of the Plant Extract Modulate the Effects of Delta9-Tetrahydrocannabinol on Fear Memory Reconsolidation. Front Behav Neurosci. 2019 Aug 1;13:174. doi: 10.3389/fnbeh.2019.00174. eCollection 2019.
PMID: 31417379BACKGROUNDTelch MJ, Rosenfield D, Lee HJ, Pai A. Emotional reactivity to a single inhalation of 35% carbon dioxide and its association with later symptoms of posttraumatic stress disorder and anxiety in soldiers deployed to Iraq. Arch Gen Psychiatry. 2012 Nov;69(11):1161-8. doi: 10.1001/archgenpsychiatry.2012.8.
PMID: 23117637BACKGROUNDZaizar ED, Papini S, O'Connor P, Telch MJ. Impact of cannabidiol-rich hemp extract oil on reconsolidation disruption of naturalistic interoceptive aversive memory in humans: Protocol for a randomized clinical trial. Contemp Clin Trials. 2022 Aug;119:106847. doi: 10.1016/j.cct.2022.106847. Epub 2022 Jul 8.
PMID: 35811050DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J. Telch, PhD
University of Texas at Austin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2021
First Posted
January 27, 2021
Study Start
January 1, 2022
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
January 19, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share