Effects of Cannabinoids on Traumatic Brain Injury

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

This study is testing if Full Spectrum and Broad Spectrum CBD can help improve symptoms like anxiety, pain, and sleep problems in adults with mild to moderate traumatic brain injury.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Drugs / interventions: pexidartinib
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT05632627 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of Full Spectrum CBD and Broad Spectrum CBD in patients with traumatic brain injury (TBI). Participants aged 18-60 with mild to moderate TBI will be randomized to receive either cannabinoid treatment or a placebo for 12 weeks. The study will assess improvements in cognition and TBI-related symptoms such as anxiety, pain, depression, and sleep disturbances. In-person visits will occur at baseline, Week 1, Week 6, and Week 12, with remote contact in the intervening weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with a history of mild to moderate traumatic brain injury and ongoing neuropsychiatric symptoms.

Not a fit: Patients with severe TBI or those currently participating in other treatment studies for TBI-related symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new therapeutic options for improving cognitive function and alleviating symptoms associated with traumatic brain injury.

How similar studies have performed: While there is emerging interest in cannabinoids for TBI, this specific approach is relatively novel and has not been extensively tested in prior studies.

Eligibility 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) or evaluation within a clinical setting, except in cases in which the TBI was acquired in a military deployment context in which medical 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-occurring medical or psychological health conditions
7. Not currently in another treatment study for TBI-related symptoms or co-occurring 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 two forms of 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 at baseline/Week 0
7. Current or lifetime diagnosis of a schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, 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 \> 24;
9. Current suicidal ideation, as indicated by Beck Depression Inventory-2 item #9 score \> 0, or C-SSRS endorsement of item #2, 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 use disorder score of 5 or greater, 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. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
14. Current diagnosis of a seizure disorder or epilepsy
15. Report using cannabis once daily or more than once daily over the last 12 months
16. Report current use of CBD for medical reasons or TBI symptoms
17. Liver function enzymes (AST, ALT) that are greater than 2x normal

Where this trial is running

Aurora, Colorado

• University of Colorado Anschutz — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Kent Hutchison, PhD — [e-mail]
• Study coordinator: Raeghan Mueller, PhD

Conditions Brain Injuries, Traumatic; TBI; CBD