Hemp-Derived Botanical Dietary Supplementation During Recovery From Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-13

Study Completion Date

2020-04-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TBI Controls

Adult men and women between 18 and 55. No prior history of traumatic brain injury. Experienced taking hemp-derived botanicals.

Hemp-derived botanical dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.

TBI HDS

Adult men and women between 18 and 55. History of traumatic brain injury. Experienced taking hemp-derived botanicals.

Hemp-derived botanical dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.

Interventions

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Hemp-derived botanical dietary supplement

Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cannabidiol CBD

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes