Effects of CBD Oil on Memory Reconsolidation and Trauma-Related Symptoms

NCT05892276 | Withdrawn

• 1 other identifier: STUDY00004278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of cannabidiol (CBD) broad-spectrum oil on memory reconsolidation (memory storage) and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation paradigm.

Conditions

Posttraumatic Stress Disorder

Keywords

Cannabidiol; CBD; PTSD; Trauma

Outcome Measures

Primary Outcomes (1)

• Momentary Assessment of Distress Scale

  The Momentary Assessment of Distress Scale (MADS) is a customizable sliding scale used to measure continuous real-time changes in levels of subjective emotional stress on scale from 0 (no distress) to 10 (extreme distress). The MADS is used to index changes in emotional reactivity during exposure to a trauma memory reactivation cue.

  Change from Baseline to Two-week Follow-up

Secondary Outcomes (6)

• Posttraumatic Stress Disorder Checklist

  Change from Baseline to Two-week Follow-up

• Posttraumatic Cognition Inventory

  Change from Baseline to Two-week Follow-up

• Posttraumatic Safety Behaviors Inventory

  Change from Baseline to Two-week Follow-up

• Posttraumatic Growth Inventory

  Change from Baseline to Two-week Follow-up

• Trauma Coping Self-Efficacy Scale

  Change from Baseline to Two-week Follow-up

Study Arms (3)

CBD-WR

EXPERIMENTAL

300 mg CBD broad-spectrum oil will be administered within the reconsolidation window. Preclinical studies demonstrate that the disruptive effects of CBD oil on memory reconsolidation depend on the timing of pharmacological administration (within 6 hours of memory reactivation). Thus, participants will be asked to take a single 300mg oral dose of CBD broad-spectrum oil immediately after the trauma memory reactivation procedure.

Behavioral: Trauma Memory Reactivation; Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil

PBO-WR

PLACEBO COMPARATOR

Placebo oil will be administered within the reconsolidation window. Participants will be asked to take a single dose of an MCT coconut oil placebo solution immediately after the trauma memory reactivation procedure.

Behavioral: Trauma Memory Reactivation; Dietary Supplement: Placebo Oil

CBD-OR

ACTIVE COMPARATOR

300mg CBD broad-spectrum oil will be administered outside of the reconsolidation window. Participants will be asked to take a single 300mg oral dose of CBD broad-spectrum oil approximately 24 hrs after the trauma memory reactivation procedure. 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.

Behavioral: Trauma Memory Reactivation; Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil

Interventions

Trauma Memory Reactivation BEHAVIORAL

Participants will be guided through the trauma memory reactivation paradigm by the study staff. The trauma memory reactivation paradigm entails two distinct procedures: (1) participants will watch a video clip related to their trauma; then (2) describe a verbal narrative of their traumatic event for approximately 5 minutes to a research team member.

CBD-OR; CBD-WR; PBO-WR

Cannabidiol (CBD) Broad-Spectrum Oil DIETARY_SUPPLEMENT

300mg CBD broad-spectrum oil.

CBD-OR; CBD-WR

Placebo Oil DIETARY_SUPPLEMENT

3ml oral dose of medium-chain triglycerides (MCT) coconut oil.

PBO-WR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 to 65;
• Fluent in written and spoken English;
• Has access to the internet;
• Access to a camera with video recording capability;
• History of trauma exposure to either a motor vehicle collision (MVC), sexual assault, physical assault, or combat;
• Willingness to refrain from all non-study cannabis use during the study period

You may not qualify if:

• Insufficient emotional reactivity to trauma video clips
• Presence of significant suicidality or a history of a suicide attempt within the past 6 months;
• History or current alcohol or substance use disorder within the past month;
• History of psychosis within the past 6 months;
• Changes in psychotropic medication (≤ 8 weeks);
• Currently receiving trauma-focused psychotherapy;
• Any medical problem that would preclude participation in the study (e.g., liver or renal abnormalities or disease);
• Any current medication that would preclude participation in the study (e.g., use of prescribed blood, such as warfarin; use of anti-seizure medications, such as valproate, lamotrigine, or clobazam; use of thyroid medications, such as levothyroxine; use of heart rhythm medications, such as amiodarone);
• Pregnant or planning to become pregnant within the next 6 weeks;
• Regular cannabis use;
• History of adverse reaction to CBD oil or other CBD products;
• Allergy to coconut or coconut oil

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The Laboratory for the Study of Anxiety Disorders, The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (3)

• Kessler RC, Aguilar-Gaxiola S, Alonso J, Benjet C, Bromet EJ, Cardoso G, Degenhardt L, de Girolamo G, Dinolova RV, Ferry F, Florescu S, Gureje O, Haro JM, Huang Y, Karam EG, Kawakami N, Lee S, Lepine JP, Levinson D, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Scott KM, Stein DJ, Ten Have M, Torres Y, Viana MC, Petukhova MV, Sampson NA, Zaslavsky AM, Koenen KC. Trauma and PTSD in the WHO World Mental Health Surveys. Eur J Psychotraumatol. 2017 Oct 27;8(sup5):1353383. doi: 10.1080/20008198.2017.1353383. eCollection 2017.

  PMID: 29075426 BACKGROUND

• Murkar 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: 31417379 BACKGROUND

• 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: 28729064 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Michael J Telch, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 7, 2023
• Study Start: August 31, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)