Healthy
Conditions
Keywords
healthy volunteers, spirituality, psilocybin, meditation
Brief summary
This study will investigate the effects of psilocybin dose and the frequency and intensity of support activities for spiritual practice (e.g., meditation) on a battery of attitudinal and behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a program of spiritual practices with the intention applying spiritual insights and knowledge to everyday life. After screening and study enrollment, each volunteer will be assigned to one of five groups that vary in dose, frequency and intensity of support for spiritual practice, and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose manipulation will be double-blind. Volunteers will be told that in each of sessions 1, 2, and 3, he/she could receive a very low, low, moderate, moderately high, or high dose of psilocybin. They will be told that each participant will receive 2 or more dose levels of psilocybin over the 2 or 3 sessions, and all participants will have one or more sessions in which he or she receives a moderately high or high dose of psilocybin. The duration of each volunteer's participation will be approximately 6 to 8 months. Each volunteer will receive several hours of preparation with the study guides in the month prior to the first psilocybin session; the first two sessions will be separated by one month. Various measures will be assessed before, during and immediately after sessions. A battery of longitudinal measures will be evaluated immediately after study enrollment, 3 weeks after the second psilocybin session, and 4 months after the second psilocybin session (6 months after study enrollment). For purposes of controlling expectancies through the 6 month follow-up evaluation, volunteers and guides will not know which volunteers or how many volunteers will be scheduled for a third session.
Interventions
DRUGpsilocybin
dose manipulation as described in the protocol and to which volunteers are blinded
BEHAVIORALIntensity of support for spiritual practice
Volunteers will be assigned to standard or high support, as described in the protocol
BEHAVIORALNumber of sessions
Volunteers will be assigned to either 2 or 3 sessions, as described in the protocol
Sponsors
Fetzer Institute
The CSP Fund of the San Francisco Foundation
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Eligibility criteria for volunteers who will receive psilocybin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hood Mysticism Scale | At end of sessions |
| States of Consciousness Questionnaire | At end of sessions |
| Persisting Effects Questionnaire | 3 weeks after each session |
Secondary
| Measure | Time frame |
|---|---|
| Brief symptom inventory | Baseline, one week after each session, and at 6 months |
| Daily spiritual experiences scale | Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session |
| Visual effects questionnaire | Baseline, 6 months, and 3 weeks after the third session |
| A battery assessing various measures of gratitude, forgiveness, religious coping, death attitude, life purpose, life satisfaction, and psychological functioning | Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session |
| Blood markers of stress and immune function | Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session |
Countries
United States
Outcome results
None listed