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Psilocybin and Spiritual Practice

Randomised, double-blind, parallel study (n=75) testing varying psilocybin dose levels (very low→high) and intensity/frequency of support for spiritual practice across 2–3 sessions in healthy volunteers.

Target Enrollment
75 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind, parallel-group study assigning 75 healthy volunteers to one of five groups varying psilocybin dose levels, intensity of support for spiritual practice, and number of psilocybin sessions (2 or 3).

Psilocybin dose is double-blind with ordinal levels from very low to high; participants receive preparation with study guides and follow-up assessments including measures immediately after sessions, 3 weeks after the second psilocybin session, and 4 months after the second session (≈6 months total participation).

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Group 1

experimental

First of 5 groups, as described in the protocol and to which volunteers are blinded

Interventions

  • Psilocybin
    via Oral• 2–3 sessions

    Dose levels vary (very low to high); double-blind; participants receive 2 or 3 psilocybin sessions; at least one moderately high or high dose.

  • Compound
    via Other

    Intensity of support for spiritual practice (standard or high).

  • Compound
    via Other

    Number of sessions: assigned to 2 or 3 sessions.

Group 2

experimental

Second of 5 groups, as described in the protocol and to which volunteers are blinded

Interventions

  • Psilocybin
    via Oral• 2–3 sessions

    Dose levels vary (very low to high); double-blind; participants receive 2 or 3 psilocybin sessions; at least one moderately high or high dose.

  • Compound
    via Other

    Intensity of support for spiritual practice (standard or high).

  • Compound
    via Other

    Number of sessions: assigned to 2 or 3 sessions.

Group 3

experimental

Third of 5 groups, as described in the protocol and to which volunteers are blinded

Interventions

  • Psilocybin
    via Oral• 2–3 sessions

    Dose levels vary (very low to high); double-blind; participants receive 2 or 3 psilocybin sessions; at least one moderately high or high dose.

  • Compound
    via Other

    Intensity of support for spiritual practice (standard or high).

  • Compound
    via Other

    Number of sessions: assigned to 2 or 3 sessions.

Group 4

experimental

Fourth of 5 groups, as described in the protocol and to which volunteers are blinded

Interventions

  • Psilocybin
    via Oral• 2–3 sessions

    Dose levels vary (very low to high); double-blind; participants receive 2 or 3 psilocybin sessions; at least one moderately high or high dose.

  • Compound
    via Other

    Intensity of support for spiritual practice (standard or high).

  • Compound
    via Other

    Number of sessions: assigned to 2 or 3 sessions.

Group 5

experimental

Fifth of 5 groups as described in the protocol and to which volunteers are blinded

Interventions

  • Psilocybin
    via Oral• 2–3 sessions

    Dose levels vary (very low to high); double-blind; participants receive 2 or 3 psilocybin sessions; at least one moderately high or high dose.

  • Compound
    via Other

    Intensity of support for spiritual practice (standard or high).

  • Compound
    via Other

    Number of sessions: assigned to 2 or 3 sessions.

Participants

Ages
21 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 21 to 70 years old
  • Have given written informed consent
  • Have a high school level of education
  • 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.
  • Have an active interest in exploring and developing their spiritual lives
  • Cigarette smokers must agree to abstain from smoking on psilocybin session days from 1 hour before psilocybin administration until at least 6 hours after psilocybin administration.
  • 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 volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session days.
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each psilocybin administration. Exceptions include caffeine and nicotine.
  • Agree not to take any PRN medications on the mornings of psilocybin sessions
  • Agree that for one week before each psilocybin 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

  • General medical exclusion criteria:
  • 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
  • Psychiatric Exclusion Criteria:
  • 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.
  • Currently meets DSM-IV criteria for Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin

Study Details

Locations

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

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