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Cannabinoid
CBD for Traumatic Brain Injury
Phase 2
Recruiting
Led By Kent Hutchison, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 6, week 0 to week 12
Summary
This trial will assess if CBD can improve cognition & symptoms related to traumatic brain injury in people. Subjects will be randomly assigned a condition for 12 weeks.
Who is the study for?
This trial is for adults aged 18-60 with mild to moderate traumatic brain injury (TBI) who have been evaluated in a hospital setting. Participants should not be involved in other TBI treatment studies, must have stable treatments for four weeks prior, and cannot change these during the study. Exclusions include severe mental illness, unstable medical conditions, high liver enzymes, current heavy cannabis or CBD use, certain neurological disorders, substance abuse issues, and pregnancy.
What is being tested?
The study tests two forms of cannabinoids (fsCBD and bsCBD) against a placebo to see if they can improve cognition and symptoms related to TBI. Participants are randomly assigned to one of these options for a duration of 12 weeks in this double-blind trial where neither the researchers nor participants know who receives the actual drug or placebo.
What are the potential side effects?
While specific side effects are not listed here, cannabinoids like fsCBD and bsCBD may cause drowsiness, changes in appetite or mood swings. Some individuals might experience digestive issues or headaches. The severity of side effects varies from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 to week 6, week 0 to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 6, week 0 to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cognition
Change in Neuropsychiatric Symptoms
Secondary study objectives
Change in Anxiety
Change in Biomarkers of Inflammation
Change in Biomarkers of Oxidative Stress
+4 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Broad Spectrum CannabidiolActive Control1 Intervention
Broad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day
Group II: Full Spectrum CannabidiolActive Control1 Intervention
Full Spectrum Cannabidiol (\<0.3% THC) Oral softgel capsule, 210mg/day
Group III: Hemp Seed OilPlacebo Group1 Intervention
Placebo Oral softgel capsule, 210mg/day
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,803 Previous Clinical Trials
2,822,003 Total Patients Enrolled
Colorado State UniversityOTHER
132 Previous Clinical Trials
38,307 Total Patients Enrolled
Kent Hutchison, PhDPrincipal Investigatorkent.hutchison@cuanschutz.edu
2 Previous Clinical Trials
601 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 60 years old.I have been diagnosed with epilepsy or seizures.I have used certain drugs or tested positive for them in the last 60 days.I am not taking any medications that can't be combined with Epidiolex.I have been diagnosed with a specific mental health condition.I am currently using CBD for medical reasons or to manage TBI symptoms.I am currently experiencing thoughts of harming myself.I have ongoing mental health symptoms from a brain injury.I do not have any major illnesses or unstable health conditions.My brain injury is classified as mild or moderate.My current treatments have been the same for the last four weeks.I have a current or past traumatic brain injury identified by a specific method.
Research Study Groups:
This trial has the following groups:- Group 1: Broad Spectrum Cannabidiol
- Group 2: Hemp Seed Oil
- Group 3: Full Spectrum Cannabidiol
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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