Status:
WITHDRAWN
Hemp-Derived Botanical Dietary Supplementation During Recovery From Brain Injury
Lead Sponsor:
Real Time Diagnostics Ventures INC
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-55 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
April 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 13 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03826368
Start Date
April 13 2020
End Date
April 13 2020
Last Update
April 15 2020
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