Psilocybin for Emotional Wellbeing Decline
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how psilocybin, a compound in magic mushrooms, affects emotional wellbeing by helping the brain adapt and change. Researchers will test various doses of psilocybin combined with either midazolam (a sedative) or a placebo to determine the best option for enhancing wellbeing. Participants will join one of four groups, receiving different treatment combinations, and will undergo procedures like MRI scans and questionnaires. This trial suits physically healthy adults who have noticed a mild decline in emotional wellbeing but do not have a major mood or anxiety disorder. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any psychotropic or CNS-altering medications at least 3 months before the screening for this trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that psilocybin, a substance found in certain mushrooms, is generally safe for humans. Studies indicate it can cause a slight increase in heart rate and blood pressure shortly after ingestion, typically about two hours later. Some individuals might experience temporary mood changes, but psilocybin has been safely used in other studies for mental health issues like depression.
Midazolam, a drug often used to help people relax or feel sleepy before surgery, is known to be safe under medical supervision. It works quickly, and its effects fade fast.
In this trial, researchers are testing different combinations of psilocybin and midazolam. Since the study is in its early stages, the main focus is on the safety of these drugs when used together. Researchers are carefully monitoring for any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about psilocybin for emotional wellbeing decline because it represents a novel approach compared to traditional treatments like antidepressants or therapy. Unlike standard medications that typically target neurotransmitters like serotonin over several weeks, psilocybin is a psychedelic compound that may rapidly promote emotional and mental health by inducing profound changes in perception and cognition. The trial explores different combinations, such as psilocybin with midazolam, which could enhance its therapeutic effects or reduce potential anxiety during the experience. This innovative use of psilocybin has the potential to offer faster and possibly longer-lasting benefits for emotional wellbeing.
What evidence suggests that this trial's treatments could be effective for emotional wellbeing decline?
Research has shown that psilocybin can boost emotional well-being by helping the brain change and adapt. Studies have found that psilocybin can lower negative feelings and anxiety, potentially aiding in the treatment of mental health issues like depression and PTSD (post-traumatic stress disorder). One study found that 54% of participants using psilocybin experienced a reduction in their symptoms. Additionally, users reported lasting decreases in anxiety and an increase in emotional understanding. In this trial, participants will receive psilocybin in different combinations, such as with IV saline or IV midazolam, to evaluate its effects on emotional well-being. These findings suggest that psilocybin may benefit emotional well-being.12567
Who Is on the Research Team?
Charles Raison, MD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
This trial is for physically healthy, English-speaking individuals who feel a mild decline in emotional wellbeing but do not have a diagnosed mood or anxiety disorder. Participants must be able to consent and complete questionnaires.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of four possible combinations of psilocybin and midazolam or placebo, undergo MRI, complete questionnaires, and undergo TMS and EEG
Follow-up
Participants are monitored for changes in wellbeing and other psychological measures
What Are the Treatments Tested in This Trial?
Interventions
- Midazolam
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Vail Health Foundation
Collaborator