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Cannabinoid
CBD Oil for Fear Memory Management
Phase 1 & 2
Waitlist Available
Led By Michael J. Telch, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two-week
Awards & highlights
Summary
This trial will test whether CBD-rich hemp oil can help reduce fear in humans by interfering with the storage of fear memories.
Who is the study for?
This trial is for adults aged 18-65 who are fluent in English and willing to avoid all non-study cannabis during the study. It's not for those with substance use disorders, certain medical conditions like heart or lung issues, high blood pressure, epilepsy, stroke, unstable psychiatric meds, low phobic response to CO2, CBD oil allergies (including coconut), significant suicidality, regular cannabis users, history of psychosis or current exposure therapy.
What is being tested?
The study examines if a CBD-rich hemp extract oil can disrupt the re-storage of fearful memories in people. Participants will have their fear memory triggered and then receive either the CBD oil or a placebo without knowing which one they're getting to see if there's a difference in how they process that fear later on.
What are the potential side effects?
While side effects aren't detailed here since it's testing efficacy primarily on memory processing rather than physical symptoms; generally speaking though CBD may cause fatigue, changes in appetite/weight and sometimes diarrhea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two-week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two-week follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CO2 Emotional Reactivity
Secondary study objectives
CO2 Emotional Distress Recovery Trajectory
Short Scale Anxiety Sensitivity Index (SASSI)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CBD-WRExperimental Treatment2 Interventions
* 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.
Group II: CBD-ORActive Control2 Interventions
* 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.
Group III: PBO-WRPlacebo Group2 Interventions
* 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.
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
370 Previous Clinical Trials
83,090 Total Patients Enrolled
Michael J. Telch, PhDPrincipal InvestigatorUniversity of Texas at Austin
2 Previous Clinical Trials
149 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: CBD-WR
- Group 2: CBD-OR
- Group 3: PBO-WR
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anxiety and Fear Patient Testimony for trial: Trial Name: NCT04726475 — Phase 1 & 2
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