Traumatic Brain Injury Research Study
The LUNA study is recruiting participants who are interested in using cannabinoids (CBD) to reduce symptoms of their traumatic brain injuries (TBI). Join our compensated study today!
Fast Facts
Diagnosed with a Traumatic Brain Injury
Ages 18-60
Compensation Provided
Conducted in Aurora, CO
Study Background
Researchers at CO Anschutz are conducting a research study to learn more about how CBD may affect sleep, anxiety, cognitive dysfunction, and inflammation related to a TBI.
Traumatic brain injuries can negatively affect your work life, interpersonal relationships, and independent living, and they can be difficult to treat. The chronic symptoms of a TBI can respond in many different ways to one treatment, and TBI patients often receive numerous therapies that may not work.
There is a growing awareness of cannabidiol (CBD) as a possible treatment for TBI, but limited scientific evidence so far. That’s where our study comes in. We want to investigate how CBD affects symptoms of TBI.
Your participation in this study may help researchers improve treatment approaches for TBI. Further research today and join our compensated study!
Study Background
Researchers at CO Anschutz are conducting a research study to learn more about how CBD may affect sleep, anxiety, cognitive dysfunction, and inflammation related to a TBI.
Traumatic brain injuries can negatively affect your work life, interpersonal relationships, and independent living, and they can be difficult to treat. The chronic symptoms of a TBI can respond in many different ways to one treatment, and TBI patients often receive numerous therapies that may not work.
There is a growing awareness of cannabidiol (CBD) as a possible treatment for TBI, but limited scientific evidence so far. That’s where our study comes in. We want to investigate how CBD affects symptoms of TBI.
Your participation in this study may help researchers improve treatment approaches for TBI. Further research today and join our compensated study!
Additional Information
The purpose of this research study is to learn more about how CBD may affect sleep, anxiety, cognitive dysfunction, and inflammation related to a TBI.
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- Ages 18-60 years old
- Diagnosed with a traumatic brain injury (TBI)
- No use of recreational drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days
- No current use of CBD for medical reasons or TBI symptoms
- No current diagnosis of a seizure disorder or epilepsy
- No current or lifetime diagnosis of a schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I & II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), or eating disorders
- Not currently pregnant, nursing, or planning/wanting to become pregnant
- Do not have an attorney in relation to the TBI
- Not currently incarcerated, paroled, or on probation
- Not currently in another treatment study for TBI-related symptoms or co-occuring medical or psychological health conditions
- If taking medications, must be stable in type, dose, and frequency for the four weeks before study enrollment
- No history of autism spectrum disorders, intellectual disability, and/or serious neurological or central nervous system disease (e.g., epilepsy, tumors, multiple sclerosis)
- No history of significant illness or unstable medical condition
- Not currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate)
If you join the study, you will be randomized to receive one of three study medications that you will take for a period of 12 weeks:
- 210 mg/day of CBD that includes trace amounts of THC (< 0.3%),
- 210 mg/day of CBD that includes no THC
- 210 mg/day of Hemp Seed Oil, which does not contain any CBD or THC
You will not know which medication group you are in.
There will be a study visit approximately each week during the 12-week period you are taking the study medication. 4 of these visits are in person, and the other 8 are conducted remotely. The first study visit will take place at the University of Colorado Anschutz Medical Campus (AMC). There will be three more in-person study appointments at AMC. You will complete weekly surveys during each remaining week during the 12-week period. Visits may include a breathalyzer test, a blood draw, a urine drug and pregnancy screen, cognitive tasks, and surveys and questionnaires, depending on the week.
Total study participation will last 12 weeks.
Compensation is provided for your time and effort.
There is no cost for you to participate in our research study.