RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-11

Study Completion:2025-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05632627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability to provide valid informed consent 2. 18-60 years old 3. Current or history of TBI as identified by the Ohio Identification Method 4. TBI severity is mild or moderate based on the VA/DoD Classification of TBI Severity 5. 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 6. 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 7. Not currently in another treatment study for TBI-related symptoms or co-occurring medical or psychological health conditions 8. 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	1. Currently incarcerated, paroled, or on probation 2. Participant has retained an attorney in relation to the TBI 3. 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 4. Vision, hearing, or communication impairments that preclude valid completion of study assessments 5. 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) 6. Evidence of poor effort (TOMMe \< 8) on neuropsychological testing at baseline/Week 0 7. 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) 8. 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; 9. 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 10. History of significant systemic illness or unstable medical condition 11. 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 12. 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; 13. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate). 14. Current diagnosis of a seizure disorder or epilepsy 15. Report using cannabis once daily or more than once daily over the last 12 months 16. Report current use of CBD for medical reasons or TBI symptoms 17. Liver function enzymes (AST, ALT) that are greater than 2x normal

Inclusion Criteria

Exclusion Criteria

1. Ability to provide valid informed consent
2. 18-60 years old
3. Current or history of TBI as identified by the Ohio Identification Method
4. TBI severity is mild or moderate based on the VA/DoD Classification of TBI Severity
5. 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
6. 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
7. Not currently in another treatment study for TBI-related symptoms or co-occurring medical or psychological health conditions
8. 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

1. Currently incarcerated, paroled, or on probation
2. Participant has retained an attorney in relation to the TBI
3. 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
4. Vision, hearing, or communication impairments that preclude valid completion of study assessments
5. 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)
6. Evidence of poor effort (TOMMe \< 8) on neuropsychological testing at baseline/Week 0
7. 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)
8. 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;
9. 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
10. History of significant systemic illness or unstable medical condition
11. 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
12. 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;
13. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
14. Current diagnosis of a seizure disorder or epilepsy
15. Report using cannabis once daily or more than once daily over the last 12 months
16. Report current use of CBD for medical reasons or TBI symptoms
17. Liver function enzymes (AST, ALT) that are greater than 2x normal

Contacts and Locations

Study Contact

Raeghan Mueller, PhD

CONTACT

3033041805

raeghan.mueller@cuanschutz.edu

Principal Investigator

Kent Hutchison, PhD

PRINCIPAL_INVESTIGATOR

kent.hutchison@cuanschutz.edu

Study Locations (Sites)

University of Colorado Anschutz

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Kent Hutchison, PhD, PRINCIPAL_INVESTIGATOR, kent.hutchison@cuanschutz.edu

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-11

Study Completion Date2025-12-15

Study Record Updates

Study Start Date2023-04-11

Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Brain Injuries, Traumatic