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

Primary Purpose

Brain Injuries, Traumatic

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) within 24 hours of injury, excepting cases in which the TBI was acquired in a military deployment context in which hospital 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-occuring medical or psychological health conditions Not currently in another treatment study for TBI-related symptoms or co-occuring 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 Exclusion Criteria: 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 barrier 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 Current or lifetime diagnosis of a schizophrenia spectrum disorder or other serious mental illness (e.g., bipolar disorder) 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 > 13; Current suicidal ideation, as indicated by Beck Depression Inventory-2 item #9 score > 0, Patient Health Questionnaire-9 item #9 score > 0, 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 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; Daily nicotine user; Report using cannabis more than once per week 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

Sites / Locations

  • University of Colorado AnschutzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Full Spectrum Cannabidiol

Broad Spectrum Cannabidiol

Hemp Seed Oil

Arm Description

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

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

Placebo Oral softgel capsule, 210mg/day

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

Change in Depression
The Beck Depression Inventory II (BDI-II) will be used to measure depressive symptoms throughout the study.
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.
Change in Sleep Disturbance
PROMIS SF v10 Sleep Disturbance 4a - a 4-item measure assessing subjective sleep quality.
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.
Change in Biomarkers of Inflammation
Circulating levels of cytokine proteins before and after will be measured using immunoassay before and after treatment
Change in Biomarkers of Oxidative Stress
Circulating levels of cytokine proteins before and after will be measured using immunoassay before and after treatment
Change in Quality of Life
The Short Form 36 will be used to measure quality of life.

Full Information

First Posted
October 24, 2022
Last Updated
April 20, 2023
Sponsor
University of Colorado, Denver
Collaborators
Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT05632627
Brief Title
Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
Official Title
Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
December 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full Spectrum Cannabidiol
Arm Type
Active Comparator
Arm Description
Full Spectrum Cannabidiol (<0.3% THC) Oral softgel capsule, 210mg/day
Arm Title
Broad Spectrum Cannabidiol
Arm Type
Active Comparator
Arm Description
Broad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day
Arm Title
Hemp Seed Oil
Arm Type
Placebo Comparator
Arm Description
Placebo Oral softgel capsule, 210mg/day
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
CBD
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo arm
Primary Outcome Measure Information:
Title
Change in Cognition
Description
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.
Time Frame
Week 0 to Week 12
Title
Change in Neuropsychiatric Symptoms
Description
The effects of study treatment (CBD or placebo) on neuropsychiatric symptoms associated with TBI will be assessed by the Neurobehavioral Symptom Inventory (NSI)
Time Frame
Week 0 to Week 12
Secondary Outcome Measure Information:
Title
Change in Depression
Description
The Beck Depression Inventory II (BDI-II) will be used to measure depressive symptoms throughout the study.
Time Frame
Week 0 to Week 12
Title
Change in Pain Intensity
Description
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.
Time Frame
Week 0 to 12
Title
Change in Sleep Disturbance
Description
PROMIS SF v10 Sleep Disturbance 4a - a 4-item measure assessing subjective sleep quality.
Time Frame
Week 0 to Week 6, Week 0 to Week 12
Title
Change in Anxiety
Description
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.
Time Frame
Week 0 to 12
Title
Change in Biomarkers of Inflammation
Description
Circulating levels of cytokine proteins before and after will be measured using immunoassay before and after treatment
Time Frame
Week 0 to Week 6, Week 0 to Week 12
Title
Change in Biomarkers of Oxidative Stress
Description
Circulating levels of cytokine proteins before and after will be measured using immunoassay before and after treatment
Time Frame
Week 0 to Week 12
Title
Change in Quality of Life
Description
The Short Form 36 will be used to measure quality of life.
Time Frame
Week 0 to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) within 24 hours of injury, excepting cases in which the TBI was acquired in a military deployment context in which hospital 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-occuring medical or psychological health conditions Not currently in another treatment study for TBI-related symptoms or co-occuring 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 Exclusion Criteria: 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 barrier 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 Current or lifetime diagnosis of a schizophrenia spectrum disorder or other serious mental illness (e.g., bipolar disorder) 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 > 13; Current suicidal ideation, as indicated by Beck Depression Inventory-2 item #9 score > 0, Patient Health Questionnaire-9 item #9 score > 0, 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 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; Daily nicotine user; Report using cannabis more than once per week 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Laurin, MS
Phone
3037242210
Email
jaime.laurin@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raeghan Mueller, PhD
Email
raeghan.mueller@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Hutchison, PhD
Organizational Affiliation
kent.hutchison@cuanschutz.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Laurin
Email
jaime.laurin@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Raeghan Mueller
Email
raeghan.mueller@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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