Hemp-Derived Botanical Dietary Supplementation During Recovery From Brain Injury

Evaluation of Hemp-Derived Botanical Dietary Supplementation to Promote Healthy Brain Function During Recovery From Brain Injury

The objective of the proposed research is to evaluate adult subjects currently taking phytocannabinoid Hemp-derived botanical supplements (HDS) during recovery from traumatic brain injury. This study seeks to answer whether subjects taking HDS formulations experience relief from self-reported symptoms or improved subjective well-being, sleep quality, cognitive benefits, side effects and/or quantifiable changes in brain state neuronal activity or stress biomarkers. We seek to answer whether regular users (once/week to multiple uses/day) of HDS experience signs of dependence, addiction or physiological withdrawal. To accomplish this we will use survey questions, quantitative EEG, cognitive testing and salivary biomarkers to determine the effectiveness of self-initiated HDS administration. In addition, we are interested in whether our objective measures allow us to understand why some people are responders to HDS health benefits while others are not.

Study Overview

• Status: Withdrawn
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Dietary supplement: Hemp-derived botanical dietary supplement

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy adults with a history of brain injury and experience taking hemp-derived phytocannabinoid hemp supplements during the recovery period. Controls without brain injury and experience with hemp supplements.

Description

Inclusion Criteria: Adult male or female volunteers between the ages of 18-55 who have experience a head trauma/ concussion resulting in the diagnosis of mild to moderate TBI (Glasgow Coma scale score between 9-14) with less than 30 minutes of unconsciousness and post-traumatic amnesia lasting less than 24 hours more than 1 month ago will be considered for participation in the study. Volunteers must be able to move about the community of the Denver metro area and speak fluent English. They must be able to leisurely ride a stationary recumbent bicycle without assistance for 10 minutes and sit stationary for 15 minutes without discomfort. They must be familiar with the brand and dosing of HDS and been regular users, defined as once /week up to multiple uses per day for at least 1 month in the past year. They must be able to hear a 25 decibels in at least one ear and respond verbally to questions while remaining still.

Exclusion Criteria:

Medications. Most subjects may continue to take medications for other conditions. However, subjects should be on stable doses of these medications for a specified period prior to beginning the study. A stable dose means that there have been no changes in the drug dosage during the past 2 months.

Subjects may not be current users of illegal drugs (e.g., cocaine, methamphetamine) Subjects may not have an immune-relevant disease (e.g. HIV, MS, Lyme Disease) Females may be pregnant or lactating and taking HDS supplementation. In the consent form we will include a warning that taking cannabis related products during pregnancy or while nursing could pose a danger to the development of the infant.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TBI Controls; Adult men and women between 18 and 55. No prior history of traumatic brain injury. Experienced taking hemp-derived botanicals.	Dietary supplement: Hemp-derived botanical dietary supplement; Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.; Other Names: Cannabidiol; CBD
TBI HDS; Adult men and women between 18 and 55. History of traumatic brain injury. Experienced taking hemp-derived botanicals.	Dietary supplement: Hemp-derived botanical dietary supplement; Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.; Other Names: Cannabidiol; CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom inventory	Sleep and broad symptom inventory	Subjects complete the symptom inventory within 30 minutes of arriving to testing facility after signing the consent forms.
qEEG frequency, brain region coherence assessment baseline measured once immediately after completion of symptom inventory at the testing facility.	Frequency power spectral analysis, coherence at baseline in control subjects and treatment group subjects.	Subjects are assessed once immediately after completion of the symptom inventory lasting approximately 10 minutes.
qEEG frequency, brain region coherence assessment, pedaling RPM change measured during a 30-40 minute window after baseline testing.	Frequency power spectral analysis, coherence before and after peddling and during memory task where the subject is asked to name or spell the months of the year backwards while pedaling and EEG measurements are taken. Auditory tones are delivered via headsets and the subject is asked to report changes when they detect a change in frequency while attending to a blinking screen.	Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Accuracy during memory task	Subjects are asked to spell the name of the months or weeks backwards while pedaling a stationary bicycle.	Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.

Collaborators and Investigators

• Sponsor: Real Time Diagnostics Ventures INC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 13, 2020
• Primary Completion (ANTICIPATED): April 13, 2020
• Study Completion (ACTUAL): April 13, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): February 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: CBD; Cannabinoid
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 2018/07/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No