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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
75
dose manipulation as described in the protocol and to which volunteers are blinded
Volunteers will be assigned to standard or high support, as described in the protocol
Volunteers will be assigned to either 2 or 3 sessions, as described in the protocol
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Hood Mysticism Scale
Time frame: At end of sessions
States of Consciousness Questionnaire
Time frame: At end of sessions
Persisting Effects Questionnaire
Time frame: 3 weeks after each session
Daily spiritual experiences scale
Time frame: Baseline, 3 weeks after second session, 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
Time frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session
Blood markers of stress and immune function
Time frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session
Brief symptom inventory
Time frame: Baseline, one week after each session, and at 6 months
Visual effects questionnaire
Time frame: Baseline, 6 months, and 3 weeks after the third session
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