Visual Surround Suppression and Perceptual... — Clinical Trial Details

Participants

Ages

25 – 65

Sexes

Male & Female

BMI

20 - 28

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
Have given written informed consent
Have at least a high-school level of education or equivalent (e.g. GED), and be able to read and write in English
General health status: Participants should be in good physical (BMI between 20.0 and 28.0 kg/m2) and psychiatric health.
Experience taking psilocybin (at the PI's discretion).
Participants must also have a person that can reliably transport them to and from the CRU for dosing session days.
Geographic location: Minnesota counties that are approximately within 1 hour driving distance to Twin Cities, including not limited to Hennepin, Ramsey, Washington, Anoka, Wright, Carver, Scott, Dakota, Sherburn
Participants must be willing to wear a face mask at all times during in-person study visits, except for dosing sessions, to ensure COVID-19 protection.
Participants must be willing to get a COVID-19 test and share results with the study team prior to all in-person visits.
Participants must be up-to-date on COVID-19 vaccines, per CDC guidelines, and share a copy of their proof of vaccination status with the study team prior to the consenting visit.
Agrees to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.

Exclusion Criteria

Exclusion Criteria:
Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except due to another medical condition), or Bipolar I or II Disorder, personality disorder, major depressive disorder, posttraumatic stress disorder, panic disorder, obsessive compulsive disorder, dysthymic disorder.
Current or past history within the last 5 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine, nicotine, and hallucinogens)
Those with a first or second-degree relative with a current or past history of meeting DSM-5 criteria for schizophrenia or other psychotic disorders or bipolar I or II disorder, because they might have an underlying genetic susceptibility for psychosis.
Presence of symptoms of the following DSM-5 disorders within the past 6 months (as assessed by the MINI-7):
* Major depressive Episode
* Suicidality
* Manic and Hypomanic Episodes
* Panic disorder
* Agoraphobia
* Social Anxiety Disorder
* Obsessive-Compulsive Disorder
* Posttraumatic Stress Disorder
* Alcohol Use Disorder
* Substance Use Disorder (Non-Alcoholic)
* Psychotic Disorders and Mood Disorders with Psychotic Features
* Anorexia Nervosa
* Bulimia Nervosa
* Binge Eating Disorder
* Generalized Anxiety Disorder
* Antisocial Personality Disorder
* Mood Disorders:
* Major Depressive Disorder (MDD)
* MDD with Psychotic Features
* Bipolar I
* Bipolar II
* Other Specified Bipolar and Related Disorder
Presence of abuse or dependence of drugs measured by the MINI-7 in the past 12 months (listed categories e.g., stimulants, cocaine, opiates, dissociatives, inhalants, cannabis, sedatives, miscellaneous).
History of medication or substance induced psychosis.
Medically significant condition considered unsuitable for the current study (e.g. diabetes, epilepsy, severe cardiovascular disease, etc)
History of suicide attempts or mania
Positive pregnancy test or currently breast-feeding
Currently taking on a regular (e.g., daily) basis any prescription medications, with the exception of birth control or other hormone therapy
A strong bias either for or against psychedelic substances, or if their responses about psychedelic use indicate that they abuse them from frequent use (more than once per month, with the exception of microdosing).
MRI EXCLUSION: head trauma, claustrophobia incompatible with scanning, cardiac pacemaker, implanted cardiac defibrillator, aneurysm brain clip, inner ear implant, prior history as a metal worker and/or certain metallic objects in the body that cannot be approved for MR scanning by the CMRR safety committee, history of clinically significant vertigo, seizure disorder, middle ear disorder, or double vision, or tattoos done less than 4 weeks from the first scheduled MRI.

Company

Product

Legal

Visual Surround Suppression and Perceptual Expectation Under Psilocybin

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Enhanced visual contrast suppression during peak psilocybin effects: Psychophysical results from a pilot randomized controlled trial

Integration

Study Arms & Interventions

Psilocybin first

Interventions

Niacin first

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators