Recruiting
Phase 1
Phase 2

CBD-Rich Oil

Sponsor:

University of Texas at Austin

Code:

NCT04726475

Conditions

Anxiety and Fear

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Interoceptive Aversive Memory Reactivation

Cannabidiol (CBD)-Rich Broad Spectrum Hemp Extract Oil

Placebo Oil

Study Details

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.

Conditions

Anxiety and Fear

Study ID

NCT04726475

Start date

Jan, 2022

Status verified date

Jan, 2022

Completion date

Jan, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion criteria include:

1. Ages 18-65
2. Fluent in English
3. Willingness to refrain from all non-study cannabis use during the study period.

Exclusion criteria include:

1. Insufficient phobicity (<50 on CO2 challenge);
2. Presence of significant suicidality;
3. History of psychosis;
4. Currently receiving exposure-based treatment;
5. Current substance use disorder;
6. Unstable psychiatric medication for a psychological condition;
7. Medical conditions contraindicating CO2 inhalation (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke);
8. 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);
9. History of an adverse reaction to CBD oil or other CBD products,
10. Coconut allergy (coconut oil is the carrier oil for CBD-rich extract)

(l) Regular cannabis use

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBD-WR

  • 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.

placebo comparator: PBO-WR

  • 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.

active comparator: CBD-OR

  • 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

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.

Cannabidiol (CBD)-Rich Broad Spectrum Hemp Extract Oil

300mg CBD-rich hemp-derived formulation in MCT coconut oil.

Placebo Oil

3ml oral dose of MCT coconut oil.

Primary outcome measure

  • CO2 Emotional Reactivity [ Time Frame: Two-week follow-up ]

Central Contacts and Locations

Central contacts

Michael J. Telch, PhD

5125604100telch@austin.utexas.edu

Eric D. Zaizar, B.A.

8303704044eric.zaizar@utexas.edu

Locations

University of Texas

Recruiting

Austin, Texas, United States, 78712

Contacts

Michael J. Telch, PhD

512-560-4100telch@austin.utexas.edu

Eric D Zaizar, B.A.

8303704044eric.zaizar@utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

Jan 19, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2022-01-19.