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

NCT01988311 | Completed Phase 1

• 1 other identifier: NA_00047665
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to finalize methods for a larger study being planned for the future. This research is being done to characterize performance of tasks, brain functioning, and the effects of psilocybin in individuals with a long-term meditation practice. There are three different parts of the pilot study:

1. 1.Effects of psilocybin on psychological function: This version of the pilot study will involve 1 or 2 day-long psilocybin sessions, and several meetings and data assessment visits. You will make a total of about 5 to 10 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus).
2. 2.Performance on behavioral and cognitive tasks: This version of the pilot study will involve completing various behavioral and cognitive tasks at our research unit. You will make a total of about 1-10 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus).
3. 3.Brain functioning: This version of the study will involve 1 to 3 brain imaging (MRI) measurements. You will make a total of about 2 to 5 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus). The MRI measurements will be taken at the F.M. Kirby Research Center at the Kennedy Krieger Institute (across the street from the Johns Hopkins Hospital).

Conditions

Psilocybin; Hallucinogens; Pharmacologic Actions; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Keywords

Psilocybin; Hallucinogens; Pharmacologic Actions; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Outcome Measures

Primary Outcomes (3)

• Persisting Effects Questionnaire

  Measures changes in spirituality, personal well-being, relationships, and emotions.

  8 weeks post session

• Hood Mysticism Scale

  Measures subjective experience associated with classical mystical experiences.

  End of session day

• States of Consciousness Questionnaire

  Measures subjective experience associated with classical mystical experiences.

  End of session day

Study Arms (3)

Drug Only

EXPERIMENTAL

psilocybin dose manipulation as described in the protocol

Drug: psilocybin

Cognitive/Behavioral Tasks Only

NO INTERVENTION

Imaging Only

NO INTERVENTION

Interventions

psilocybin DRUG

dose manipulation as described in the protocol

Drug Only

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing 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
• Current or past history of meeting DSM-IV criteria for 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 meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression
• Have a first or second-degree relative with Schizophrenia, Psychotic Disorder (unless substance induced or due to a medical condition), or Bipolar I or II Disorder
• Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
• Head trauma
• Claustrophobia
• Cardiac pacemaker
• Implanted cardiac defibrillator

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• DiRenzo D, Barrett FS, Perin J, Darrah E, Christopher-Stine L, Griffiths RR. Impact of Psilocybin on Peripheral Cytokine Production. Psychedelic Med (New Rochelle). 2024 Jun 17;2(2):109-115. doi: 10.1089/psymed.2023.0039. eCollection 2024 Jun.

  PMID: 40051582 DERIVED

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Roland R Griffiths, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 20, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)