Brain Injuries, TraumaticPhase 2NCT05632627
Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
A Phase 2 study testing Cannabidiol in people with Brain Injuries, Traumatic, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 7 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Cannabidiol, Placebo
- Keywords
- TBI, CBD
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
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.
PlaceboDrug
Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Full Spectrum Cannabidiol | Active comparator | Full Spectrum Cannabidiol (<0.3% THC) Oral softgel capsule, 210mg/day Receives: Drug: Cannabidiol |
| Broad Spectrum Cannabidiol | Active comparator | Broad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day Receives: Drug: Cannabidiol |
| Hemp Seed Oil | Placebo comparator | Placebo Oral softgel capsule, 210mg/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Week 0 to Week 12
Secondary outcomes (7)
Change in Biomarkers of Inflammation
Circulating levels of cytokine proteins before and after will be measured using immunoassay before and after treatment
Measured: Week 0 to Week 6, Week 0 to Week 12
Change in Biomarkers of Oxidative Stress
Circulating levels of cytokine proteins before and after will be measured using immunoassay before and after treatment
Measured: Week 0 to Week 12
Change in Pain Intensity
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.
Measured: Week 0 to 12
Change in Anxiety
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.
Measured: Week 0 to 12
Change in Sleep Disturbance
PROMIS SF v10 Sleep Disturbance 4a - a 4-item measure assessing subjective sleep quality.
Measured: Week 0 to Week 6, Week 0 to Week 12
Change in Quality of Life
The Short Form 36 will be used to measure quality of life.
Measured: Week 0 to Week 12
Change in Depression
The Beck Depression Inventory II (BDI-II) will be used to measure depressive symptoms throughout the study.
Measured: Week 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start11 Apr 2023
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Sponsor
- Investigators
- Kent Hutchison, PhD, Principal investigator, kent.hutchison@cuanschutz.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632627
- Sponsor's protocol ID
- 22-1427
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05632627
- Acronym / sponsor ID
- 22-1427
- Conditions
- Brain Injuries, Traumatic
- Keywords
- TBI, CBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full Spectrum Cannabidiol | Active comparator | Drug: CannabidiolFull Spectrum Cannabidiol (<0.3% THC) Oral softgel capsule, 210mg/day |
| Broad Spectrum Cannabidiol | Active comparator | Drug: CannabidiolBroad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day |
| Hemp Seed Oil | Placebo comparator | Drug: PlaceboPlacebo Oral softgel capsule, 210mg/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: CBDThe 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. | Drug | Broad Spectrum Cannabidiol, Full Spectrum Cannabidiol |
| PlaceboPlacebo arm | Drug | Hemp Seed Oil |
Primary outcome
Change in Neuropsychiatric Symptoms
Time frame: 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
Time frame: 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.
7 secondary outcomes
Change in Biomarkers of Inflammation
Time frame: Week 0 to Week 6, Week 0 to Week 12
Change in Biomarkers of Oxidative Stress
Time frame: Week 0 to Week 12
Change in Pain Intensity
Time frame: Week 0 to 12
Change in Anxiety
Time frame: Week 0 to 12
Change in Sleep Disturbance
Time frame: Week 0 to Week 6, Week 0 to Week 12
Change in Quality of Life
Time frame: Week 0 to Week 12
Change in Depression
Time frame: Week 0 to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Hutchison, PhD principal investigator
kent.hutchison@cuanschutz.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Brain Injuries, Traumatic, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuropsychiatric Symptoms (time frame: Week 0 to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.