Thank you for your interest in our study on Traumatic Brain Injuries (LUNA Study)!

There are a few things about this study that you may like to know before you decide to participate:

  • This study plans to learn more about cannabidiol (CBD) in Traumatic Brain Injury (TBI) symptoms.
  • You are being asked to be in this research study because you have expressed a desire to use CBD to reduce your TBI symptoms.
  • 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, or 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.
  • 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.
  • Total compensation for the study can be up to $220.

Before we schedule your first appointment, it would be helpful to see if you are likely to qualify to be in the study. In order to do this, I would like to ask you some eligibility questions, which will include questions about your Traumatic Brain Injury (TBI), and overall health, including prior and current alcohol and drug use. It should take about 10 minutes to go through these questions.

  • Some of the questions may make you uncomfortable; you do not have to answer any question that you would not like to answer, but without answers to these questions, you will not be eligible to participate in the study.
  • We will not save your name or any other information that would identify you until we know you have qualified for the study; at that time, we will keep this information secure.
  • If you do not qualify for this study, we will immediately destroy any information we have collected.
  • We are also required to give you the number of COMIRB, the Ethics Board that oversees our research: it is 303.724.1055, in case you have any questions or concerns for them.


Version Date: June 21, 2023

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