Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
Study Details
Study Description
Brief Summary
This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to improve cognition and traumatic brain injury-related symptoms. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of patients with traumatic brain injury.
This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to improve cognition and TBI-related symptoms such as anxiety, pain, depression, and sleep. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
The initial Week 0 / Baseline visit will take place at the University of Colorado Anschutz Medical Campus. There will be in-person visits at Weeks 1, 6, and 12. Participants will be contacted remotely each remaining week during the 12-week period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Full Spectrum Cannabidiol Full Spectrum Cannabidiol (<0.3% THC) Oral softgel capsule, 210mg/day |
Drug: Cannabidiol
The current study will directly test the hypothesis that a moderate dose of CBD leads to improvements in cognition, TBI-related symptoms, pain, sleep, depression, anxiety, and peripheral markers of inflammation and oxidative stress.
Other Names:
|
| Active Comparator: Broad Spectrum Cannabidiol Broad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day |
Drug: Cannabidiol
The current study will directly test the hypothesis that a moderate dose of CBD leads to improvements in cognition, TBI-related symptoms, pain, sleep, depression, anxiety, and peripheral markers of inflammation and oxidative stress.
Other Names:
|
| Placebo Comparator: Hemp Seed Oil Placebo Oral softgel capsule, 210mg/day |
Drug: Placebo
Placebo arm
|
Outcome Measures
Primary Outcome Measures
- Change in Cognition [Week 0 to Week 12]
The effects of study treatment (CBD or placebo) on attention, processing speed, working memory, long-term memory recall, and executive function will be assessed using the Trail Making Test; the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span, Symbol Search, Coding, Letter-Number Sequencing; and HVLT delayed recall, to create domain scores used to inform an aggregate measure of cognition.
- Change in Neuropsychiatric Symptoms [Week 0 to Week 12]
The effects of study treatment (CBD or placebo) on neuropsychiatric symptoms associated with TBI will be assessed by the Neurobehavioral Symptom Inventory (NSI)
Secondary Outcome Measures
- Change in Depression [Week 0 to Week 12]
The Beck Depression Inventory II (BDI-II) will be used to measure depressive symptoms throughout the study.
- Change in Pain Intensity [Week 0 to 12]
PROMIS Pain Intensity 1a - A single-item measure of pain intensity. Average pain in the last 7 days is recorded on a scale of 1 - 10, with higher scores indicating higher pain levels.
- Change in Sleep Disturbance [Week 0 to Week 6, Week 0 to Week 12]
PROMIS SF v10 Sleep Disturbance 4a - a 4-item measure assessing subjective sleep quality.
- Change in Anxiety [Week 0 to 12]
PROMIS Anxiety SF - An 8-item measure to rate subjective anxiety symptoms. Possible scores range from 1 - 5 with higher scores indicating worse anxiety symptoms.
- Change in Biomarkers of Inflammation [Week 0 to Week 6, Week 0 to Week 12]
Circulating levels of cytokine proteins before and after will be measured using immunoassay before and after treatment
- Change in Biomarkers of Oxidative Stress [Week 0 to Week 12]
Circulating levels of cytokine proteins before and after will be measured using immunoassay before and after treatment
- Change in Quality of Life [Week 0 to Week 12]
The Short Form 36 will be used to measure quality of life.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to provide valid informed consent
-
18-60 years old
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Current or history of TBI as identified by the Ohio Identification Method
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TBI severity is mild or moderate based on the VA/DoD Classification of TBI Severity
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TBI event must have resulted in hospital evaluation (emergency department or other hospital-based assessment) within 24 hours of injury, excepting cases in which the TBI was acquired in a military deployment context in which hospital services were not immediately available
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Ongoing neuropsychiatric symptoms (i.e., depressive, anxiety, pain, cognitive complaints, or sleep complaints) that are plausibly associated with TBI and not better accounted for by co-occuring medical or psychological health conditions
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Not currently in another treatment study for TBI-related symptoms or co-occuring medical or psychological health conditions
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Co-occurring treatments must be stable in type, dose, and frequency for the four weeks preceding study enrollment and participants must commit to making no changes in these co-occurring treatments during the study
Exclusion Criteria:
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Currently incarcerated, paroled, or on probation
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Participant has retained an attorney in relation to the TBI
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Pregnant at the time of study enrollment or unwilling to commit to the use of barrier contraception throughout the duration of the study
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Vision, hearing, or communication impairments that preclude valid completion of study assessments
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History of autism spectrum disorders, intellectual disability, and/or serious neurological or central nervous system disease that would be expected to affect cognition (e.g., epilepsy, tumors, multiple sclerosis)
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Evidence of poor effort (TOMMe < 8) on neuropsychological testing
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Current or lifetime diagnosis of a schizophrenia spectrum disorder or other serious mental illness (e.g., bipolar disorder) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022)
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Meets criteria for major depressive episode as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022) and with a Beck Depression Inventory-2 score > 13;
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Current suicidal ideation, as indicated by Beck Depression Inventory-2 item #9 score > 0, Patient Health Questionnaire-9 item #9 score > 0, or verbal or written report of current suicidal ideation by the participant to any study team member
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History of significant systemic illness or unstable medical condition
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Alcohol or substance use disorder, based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022), in the six months preceding study enrollment;
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Reported use of other drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days or test positive on a urine test for those drugs of abuse at baseline;
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Daily nicotine user;
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Report using cannabis more than once per week over the last 12 months;
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Report current use of CBD for medical reasons or TBI symptoms
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Liver function enzymes (AST, ALT) that are greater than 2x normal
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Colorado, Denver
- Colorado State University
Investigators
- Principal Investigator: Kent Hutchison, PhD, kent.hutchison@cuanschutz.edu
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-1427