Research Study Title: Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder
Principal Investigator: Peggy Nopoulos
This sheet provides key information you need to know about participating in this research study. Taking part in a research study is voluntary. You don't need to take part in this study to receive care for your condition. You can stop taking part in this study at any time without any penalty. Feel free to ask the researchers any questions you have about this study. The full informed consent document includes detailed information about the study.
The purpose of the research study: The purpose of this study is to see if psychedelic-assisted psychotherapy is helpful for people struggling with their alcohol use and to collect data that measures the effects of psychedelics.
Main procedures you will undergo if you take part in this research study: You will be assigned to either the control group or the active-comparator group. In either group, you will receive four psychotherapy sessions. If assigned to the active-comparator group, you will receive a guided session with ketamine. If assigned to the intervention group, you will receive a guided psilocybin session. In either group, you will undergo a medical evaluation (including a blood draw and EKG), three MRI scans, and will complete questionnaires and cognitive tasks. If you are in the active-comparator group, you will be given the option to complete the psilocybin protocol later.
Number study visits and how long study visits will be: This study will entail 7 in-person visits along with several phone calls. The baseline assessment will take up to 8 hours. Two of the psychotherapy sessions will last approximately 2-4 hours to include surveys and tasks. Two of the therapy sessions will last approximately 3-4 hours. The drug administration with therapy visit will last until the effects of the drug wear off (up to 9 hours). The final in-person assessment will last approximately 4 hours. The phone calls will take approximately 30 minutes each.
How long you will be in the study: Your participation in the study will last for up to 12 weeks. If you are assigned to the ketamine condition, you will be given the option to complete the psilocybin protocol later. This will take up to an additional 7 weeks.
Reasons why I may or may not want to participate in this study: This study entails several long visits to UIHC. This may require you to take time off from work. We will also ask that you be abstinent from alcohol on the drug administration day. If you are not abstinent from alcohol (as indicated by a breathalyzer of over 0), you will have to reschedule your drug administration visit. You will only be allowed to reschedule this visit once.
Main risks of taking part in this research study: Potential side effects from the study drugs (ketamine and psilocybin) include GI upset, cardiovascular changes, headache, anxiety/ negative emotional states, dissociation, transient cognitive changes, and increased urinary frequency. The most common side effects of the rescue medication diazepam (used in case of adverse reaction) is drowsiness.
Possible benefits of taking part in this research study: We don't know if you will benefit from this study. However, we hope that in the future other people might benefit from this study because we will better understand the effects of psilocybin and of ketamine on people struggling with their alcohol use.