Frequently Asked Questions
What is the goal of this research study?
The Ketamine-Assisted Psychotherapy for Teens with PTSD study aims to find out if getting ketamine with counseling help is safe and makes teens with post-traumatic stress disorder (PTSD) feel better.
What is ketamine?
Ketamine is a medicine that is only allowed for doctors to use and is approved by the Food and Drug Administration (FDA) to help people not feel pain during doctor exams and surgeries. In this study, doctors will give ketamine through an IV to see if it can safely help teens with PTSD. Doctors know a lot about ketamine and its risks already. Other studies showed ketamine can be given safely to teens who are very sad, but we don’t know if it will help teens with PTSD or not.
Who is eligible to participate?
Teens ages 15-17 who have a current PTSD diagnosis and are medically and neurologically healthy are eligible. Participants need to speak and read English to participate in this study.
What will happen if I join the study?
Eligible teens will be asked to participate in the following…
- Participate in a screening visit (it may take a few hours) where we see if you can be in the study. During this visit you will be asked to:
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- Provide your contact information
- Answer questions about your health history and medicines you take
- Have a physical checkup by a doctor on our study team
- Including checking your heartbeat, height, weight, and doing an ECG (checking your heart activity with skin electrodes)
- Provide urine (pee) and blood samples
- Answer questions about how you feel, think, and about events that have happened in your lifetime
- Complete one to three sessions before the ketamine to prepare for receiving the medicine. You will be asked to:
- Talk with the two therapists who will be with you during your ketamine sessions about your thoughts, feelings, and about what will happen during sessions
- Answer questions about your thoughts, feelings, behaviors, and events that have happened in your lifetime
- Do safety checks with the therapists to make sure it is safe for you to receive the medicine
- Complete up to three medicine sessions where you will be asked to:
- Wear a headband that records what your brain is doing while you sleep at home for 7 nights during your first medicine session. You will wear it 3 days before the medicine, on the night of the medicine session, and three nights after. (You will not wear this headband for medicine sessions 2 or 3)
- Arrive at American Family Children’s Hospital for the medicine sessions
- Provide urine (pee) and blood samples
- Answer some questions about your health, thoughts and feelings
- Get the medicine (ketamine) through an IV
- Participate in therapy with two doctors while having the medicine
- Complete one to three therapy session with study therapists after each ketamine session where you will be asked to:
- Talk about what happened in the medicine session
- Answer questions about your thoughts, feelings, behaviors, and events that have happened in your lifetime
- Do safety checks with the therapists to make sure it is safe for you to receive the medicine
What will I receive if I join the study?
You will be paid up to $895 for your time and effort. You will get $200 when you finish the activities that decide if you can be in the study and the sessions that help you prepare for the medicine sessions. You will get $100 after each of your medicine sessions, and $35 for every night you wear the sleep equipment we loan to you. You will get an additional $150 when you finish all the study activities.
Why might I want to participate?
- You don’t mind the researchers asking you questions about how you feel and your health
- You’re okay with giving some blood and pee for tests
- You can commit to being in the study for 2-3 months and following the schedule
- You want to help scientists learn even if you don’t get anything from it
Why might I not want to participate?
- You don’t like needles or getting your blood drawn
- Giving blood samples makes you nervous
- You might be too busy to answer surveys
- You don’t feel comfortable answering the questions
Will this study be billed to my insurance?
The counseling, medicine, and lab tests (pee and blood) will not be billed to your insurance, though the results may be entered into your medical record.
Will I get to see the results from the tests I do for this study?
The tests you do for this study are just for research. Most of the study data will not be included in your medical record. If one of the tests shows something abnormal that could be important, the doctor in the study will tell you about it. If the questionnaires you fill out in this study show that you are feeling sad or worried a lot, then the study team may talk to your therapist if you have one. If you do not have one, they will give you a list of places near you that can help with these feelings.
Where can I get more information?
You can email us at kap@psychiatry.wisc.edu, call us at 608-265-3610, or download the consent form at the bottom of this webpage for more information.
KAP Study Consent Form