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

Completed · Phase 2 · Has a placebo group

Conditions studied: Brain Injuries, Traumatic

In brief

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.

Key facts

Study ID

NCT05632627

Run by

University of Colorado, Denver

People needed

43

Starts

2023-04-11

Expected to finish

2025-07-07

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to provide valid informed consent
• 18-60 years old
• Current or history of TBI as identified by the Ohio Identification Method
• TBI severity is mild or moderate based on the VA/DoD Classification of TBI Severity
• 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
• 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
• Not currently in another treatment study for TBI-related symptoms or co-occurring medical or psychological health conditions
• 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

You may not qualify if…

• Currently incarcerated, paroled, or on probation
• Participant has retained an attorney in relation to the TBI
• 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
• Vision, hearing, or communication impairments that preclude valid completion of study assessments
• 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)
• Evidence of poor effort (TOMMe < 8) on neuropsychological testing at baseline/Week 0
• 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)
• 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;
• 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
• History of significant systemic illness or unstable medical condition
• 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
• 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;
• Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
• Current diagnosis of a seizure disorder or epilepsy
• Report using cannabis once daily or more than once daily over the last 12 months
• Report current use of CBD for medical reasons or TBI symptoms
• Liver function enzymes (AST, ALT) that are greater than 2x normal

Where it is running

• University of Colorado Anschutz — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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