Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2025-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Colorado State University
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

1. Ability to provide valid informed consent

2. 18-60 years old

3. Current or history of TBI as identified by the Ohio Identification Method

4. TBI severity is mild or moderate based on the VA/DoD Classification of TBI Severity

5. 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

6. 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

7. Not currently in another treatment study for TBI-related symptoms or co-occuring medical or psychological health conditions

8. 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:

1. Currently incarcerated, paroled, or on probation

2. Participant has retained an attorney in relation to the TBI

3. Pregnant at the time of study enrollment or unwilling to commit to the use of barrier contraception throughout the duration of the study

4. Vision, hearing, or communication impairments that preclude valid completion of study assessments

5. 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)

6. Evidence of poor effort (TOMMe < 8) on neuropsychological testing

7. 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)

8. 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;

9. 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

10. History of significant systemic illness or unstable medical condition

11. 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;

12. 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;

13. Daily nicotine user;

14. Report using cannabis more than once per week over the last 12 months;

15. Report current use of CBD for medical reasons or TBI symptoms

16. Liver function enzymes (AST, ALT) that are greater than 2x normal