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

NCT05632627 | Completed Phase 2 FDA Drug

• 1 other identifier: 22-1427
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Keywords

TBI; CBD

Outcome Measures

Primary Outcomes (2)

• Change in Neuropsychiatric Symptoms

  The effects of study treatment (CBD or placebo) on neuropsychiatric symptoms associated with TBI will be assessed by the Neurobehavioral Symptom Inventory (NSI)

  Week 0 to Week 12

• Change in Cognition

  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.

  Week 0 to Week 12

Secondary Outcomes (7)

• Change in Biomarkers of Inflammation

  Week 0 to Week 6, Week 0 to Week 12

• Change in Biomarkers of Oxidative Stress

  Week 0 to Week 12

• Change in Pain Intensity

  Week 0 to 12

• Change in Anxiety

  Week 0 to 12

• Change in Sleep Disturbance

  Week 0 to Week 6, Week 0 to Week 12

Study Arms (3)

Full Spectrum Cannabidiol

ACTIVE COMPARATOR

Full Spectrum Cannabidiol (\<0.3% THC) Oral softgel capsule, 210mg/day

Drug: Cannabidiol

Broad Spectrum Cannabidiol

ACTIVE COMPARATOR

Broad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day

Drug: Cannabidiol

Hemp Seed Oil

PLACEBO COMPARATOR

Placebo Oral softgel capsule, 210mg/day

Drug: Placebo

Interventions

Cannabidiol DRUG

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.

Also known as: CBD

Broad Spectrum Cannabidiol; Full Spectrum Cannabidiol

Placebo DRUG

Placebo arm

Hemp Seed Oil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide valid informed consent
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado State University: collaborator

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Kent Hutchison, PhD

  kent.hutchison@cuanschutz.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 30, 2022
• Study Start: April 11, 2023
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)