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Cannabinoid

CBD Oil for Fear Memory Management

Q: To what extent is the population participating in this trial expanding?

Affirmative. The records hosted on clinicaltrials.gov display that this trial is currently accepting applicants, which began recruitment on January 1st of 2022 and was last updated in early March. 96 participants are needed from a single research facility.

Q: What is the overarching objective of this medical experiment?

The primary outcome for this trial, assessed over a two-week posttreatment and one month follow-up period is measured using the Behavioral Approach Test (BAT)-Peak Distress. Secondary metrics include Panic Disorder Severity Scale-Self Report (PDS-SR) change from baseline, <a href="https://www.withpower.com/clinical-trials/anxiety">Anxiety</a> Sensitivity Index 3 (ASI-3) transformation since initiation of treatment, and evaluation of panic appraisals with PAIs 1, 2 &#x26; 3.

Q: What are the criteria for participants to qualify for this research trial?

Eligibility requirements for this medical trial demand that applicants are suffering from agoraphobia and aged between 18 and 65. Currently, the research team is in search of approximately 96 individuals to participate.

Q: Are elderly individuals being recruited for the research project?

The age range for eligibility in this trial is between 18 and 65 years old.

Q: Is enrollment still open for this experiment?

According to clinicaltrials.gov, this experiment is actively seeking volunteers and was initially posted on the 1st of January 2022 with a last edit date of 3rd March 2021.

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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and two-week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CO2 Emotional Reactivity

Secondary outcome measures

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of Texas at AustinLead Sponsor

353 Previous Clinical Trials

81,148 Total Patients Enrolled

Michael J. Telch, PhDPrincipal InvestigatorUniversity of Texas at Austin

2 Previous Clinical Trials

149 Total Patients Enrolled

Media Library

CBD-Rich Oil (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04726475 — Phase 1 & 2

Anxiety and Fear Research Study Groups: CBD-WR, CBD-OR, PBO-WR

Anxiety and Fear Clinical Trial 2023: CBD-Rich Oil Highlights & Side Effects. Trial Name: NCT04726475 — Phase 1 & 2

CBD-Rich Oil (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04726475 — Phase 1 & 2

Anxiety and Fear Patient Testimony for trial: Trial Name: NCT04726475 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the population participating in this trial expanding?

"Affirmative. The records hosted on clinicaltrials.gov display that this trial is currently accepting applicants, which began recruitment on January 1st of 2022 and was last updated in early March. 96 participants are needed from a single research facility."

Answered by AI

What is the overarching objective of this medical experiment?

"The primary outcome for this trial, assessed over a two-week posttreatment and one month follow-up period is measured using the Behavioral Approach Test (BAT)-Peak Distress. Secondary metrics include Panic Disorder Severity Scale-Self Report (PDS-SR) change from baseline, Anxiety Sensitivity Index 3 (ASI-3) transformation since initiation of treatment, and evaluation of panic appraisals with PAIs 1, 2 & 3."

Answered by AI

What are the criteria for participants to qualify for this research trial?

"Eligibility requirements for this medical trial demand that applicants are suffering from agoraphobia and aged between 18 and 65. Currently, the research team is in search of approximately 96 individuals to participate."

Answered by AI

Are elderly individuals being recruited for the research project?

"The age range for eligibility in this trial is between 18 and 65 years old."

Answered by AI

Is enrollment still open for this experiment?

"According to clinicaltrials.gov, this experiment is actively seeking volunteers and was initially posted on the 1st of January 2022 with a last edit date of 3rd March 2021."

Answered by AI