Pilot Study: Effects of Psilocybin on Behavior,... — Clinical Trial Details

Participants

Ages

25 – 80

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

25 to 80 years old
Have given written informed consent
Have some college-level education (college degree preferred)
Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. Participants will be required to be non-smokers.
Agree not to take any PRN medications on the mornings of drug sessions
Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.

Exclusion Criteria

Women who are pregnant or nursing; women of child-bearing potential and sexually active who are not practising an effective means of birth control
Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), or TIA in the past year
Epilepsy with history of seizures
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting pharmacological effect on serotonin neurons or medications that are MAO inhibitors. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table
Psychiatric exclusions: Current or past history of Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder; current or past history within the last 5 years of alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression; first- or second-degree relative with Schizophrenia, Psychotic Disorder (unless substance induced or due to a medical condition), or Bipolar I or II Disorder; psychiatric condition judged incompatible with safe exposure to psilocybin
fMRI exclusions: Head trauma; Claustrophobia; Cardiac pacemaker; Implanted cardiac defibrillator; Aneurysm brain clip; Inner ear implant; Artificial heart valve (last 6 weeks); Prior history as a metal worker and/or certain metallic objects in the body

Company

Product

Legal

Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Drug Only

Interventions

Cognitive/Behavioral Tasks Only

Imaging Only

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators