Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
- Registration Number
- NCT05632627
- Lead Sponsor
- University of Colorado, Denver
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hemp Seed Oil Placebo Placebo Oral softgel capsule, 210mg/day Full Spectrum Cannabidiol Cannabidiol Full Spectrum Cannabidiol (\<0.3% THC) Oral softgel capsule, 210mg/day Broad Spectrum Cannabidiol Cannabidiol Broad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day
- Primary Outcome Measures
Name Time Method 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)
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.
- Secondary Outcome Measures
Name Time Method 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 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 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 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 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 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 Quality of Life Week 0 to Week 12 The Short Form 36 will be used to measure quality of life.
Trial Locations
- Locations (1)
University of Colorado Anschutz
🇺🇸Aurora, Colorado, United States