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Use of CBD Oil in the Treatment of Panic Attack-Related Fear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04726475
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : March 1, 2021
Sponsor:
Collaborator:
Way West Hemp Inc.
Information provided by (Responsible Party):
University of Texas at Austin

Brief Summary:
The purpose of this study is to test whether cannabidiol (CBD) can interfere with the reconsolidation (storage) of pathological fear memory in humans.

Condition or disease Intervention/treatment Phase
Panic Attacks Panic Disorder Agoraphobia Behavioral: Memory Reactivation Dietary Supplement: Cannabidiol (CBD) Oil Dietary Supplement: Placebo Oil Phase 1 Phase 2

Detailed Description:

The overarching goal of the proposed research project is to contribute towards the development of a novel ultra-brief intervention for anxiety-related psychiatric disorders such as panic disorder and post-traumatic stress disorder (PTSD). Building off innovative work in the basic neuroscience of fear memory interference (see Stern et al., 2018 for a review), this experiment will be the first to evaluate whether cannabidiol (CBD) can interfere with the reconsolidation of naturally acquired pathological interoceptive fear memory in humans.

Participants who meet DSM-5 criteria for panic disorder or subthreshold elevated concerns about having additional panic attacks will be randomly assigned to one of three conditions: (1). Memory reactivation + CBD, (2). Memory reactivation+ Placebo, or (3). CBD alone.

NOTE: Due to the COVID-19 Pandemic all study procedures will occur online and over videoconference with study staff. Additionally, CBD or placebo oil will be mailed to the participant's location.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cannabidiol (CBD) on Reconsolidation Disruption of Pathological Interoceptive Aversive Memory in Humans.
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Memory Reactivation + CBD Oil
Immediately after the brief memory reactivation procedure (see interventions), participants will be asked to take a single 300mg oral dose of CBD oil.
Behavioral: Memory Reactivation
A script-driven imagery approach adapted from prior research (see Brunet et al., 2018) will be used for the memory reactivation procedure. Specifically, participants will be instructed to write a brief one-page narrative in the present tense, first-person singular, focusing on their worst panic attack's most disturbing moments. The participant will then be asked to read the narrative aloud "as if they were back in the event" and record it on a recording device. Lastly, the participant will be asked to close their eyes and listen to their recording once while focusing intensely on their panic memory.

Dietary Supplement: Cannabidiol (CBD) Oil
Participants will be asked to take a single 300mg oral dose of a hemp-derived formulation of purified isolate cannabidiol oil. Study CBD was prepared by Way West Hemp Inc. and cannabinoid potency testing has been performed by Botanacor Laboratories. Botanacor conducts potency testing that is in accordance with FDA-compliant Pharma practices.

Placebo Comparator: Memory Reactivation + Placebo Oil
Immediately after the brief memory reactivation procedure (see interventions), participants will be asked to take a single 300mg oral dose of placebo oil.
Behavioral: Memory Reactivation
A script-driven imagery approach adapted from prior research (see Brunet et al., 2018) will be used for the memory reactivation procedure. Specifically, participants will be instructed to write a brief one-page narrative in the present tense, first-person singular, focusing on their worst panic attack's most disturbing moments. The participant will then be asked to read the narrative aloud "as if they were back in the event" and record it on a recording device. Lastly, the participant will be asked to close their eyes and listen to their recording once while focusing intensely on their panic memory.

Dietary Supplement: Placebo Oil
Participants will be asked to take a single 300mg oral dose of MCT oil.

Active Comparator: CBD Oil alone
Participants will be asked to take a single 300mg oral dose of CBD oil.
Dietary Supplement: Cannabidiol (CBD) Oil
Participants will be asked to take a single 300mg oral dose of a hemp-derived formulation of purified isolate cannabidiol oil. Study CBD was prepared by Way West Hemp Inc. and cannabinoid potency testing has been performed by Botanacor Laboratories. Botanacor conducts potency testing that is in accordance with FDA-compliant Pharma practices.




Primary Outcome Measures :
  1. Behavioral Approach Test (BAT)-Peak Distress [ Time Frame: 2-week posttreatment and 1-month follow-up ]
    Change from baseline in peak subjective distress (0-100) during a behavioral approach test (BAT) involving a voluntary hyperventilation challenge for up to 2 min.

  2. Behavioral Approach Test (BAT)-Persistence Time [ Time Frame: 2-week posttreatment and 1-month follow-up ]
    Change from baseline in persistence time (0-120 sec.) during a behavioral approach test (BAT) involving a voluntary hyperventilation challenge for up to 2 min.


Secondary Outcome Measures :
  1. Panic Disorder Severity Scale-Self Report (PDS-SR) [ Time Frame: 2-week posttreatment and 1-month follow-up ]
    Change from baseline on the Panic Disorder Severity Scale

  2. Panic Appraisal Inventories (PAI's 1,2, & 3) [ Time Frame: 2-week posttreatment and 1-month follow-up ]
    Change from baseline on PAI's 1,2, & 3

  3. Acute Panic Inventory (API) [ Time Frame: 2-week posttreatment and 1-month follow-up ]
    Change from baseline in level of panic symptoms as measured by the Acute Panic Inventory long form (API) after the BAT.

  4. Anxiety-Sensitivity Index-3 (ASI-3) [ Time Frame: 2-week posttreatment and 1-month follow-up ]
    Change from baseline on the ASI-3

  5. Brief Symptom Log [ Time Frame: Completed once 1 day morning after baseline and once 1 day morning after treatment ]
    Change from baseline on an online symptom log



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

Inclusion Criteria:

  1. Meets for a current DSM-5 diagnosis of Panic Disorder or subthreshold elevated concerns about having additional panic attacks.
  2. Ability to identify a single worst panic memory for reactivation.
  3. Insufficient phobicity (Peak fear < 50 on BAT)
  4. Age between 18 to 65
  5. Fluent in English
  6. Willingness to refrain from all non-study cannabis use during the study period.

Exclusion Criteria:

  1. Presence of significant suicidality
  2. History of psychosis
  3. Currently receiving exposure-based treatment for panic disorder.
  4. Current substance use disorder
  5. Unstable medication for a psychological condition.
  6. Medical conditions contraindicating voluntary hyperventilation (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke).
  7. 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)
  8. History of adverse reaction to CBD oil or other CBD products
  9. Allergic to coconut oil (coconut oil is the carrier oil for the CBD isolate and placebo)

Information from the National Library of Medicine

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


Contacts
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Contact: Michael J. Telch, PhD 5125604100 telch@austin.utexas.edu
Contact: Eric D. Zaizar, B.A. 8303704044 eric.zaizar@utexas.edu

Locations
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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   
Sponsors and Collaborators
University of Texas at Austin
Way West Hemp Inc.
Investigators
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Principal Investigator: Michael J. Telch, PhD University of Texas at Austin
Additional Information:
Publications:
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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: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Panic Disorder
Agoraphobia
Anxiety Disorders
Mental Disorders
Epidiolex
Anticonvulsants