Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
NCT Number: NCT00802282
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.
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Notify Me21 year–70 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21224, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Eligibility criteria for volunteers who will receive psilocybin
Inclusion criteria
Exclusion criteria
General medical exclusion criteria:
Psychiatric Exclusion Criteria:
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
Time frame: At end of sessions
Time frame: At end of sessions
Time frame: 3 weeks after each session
Time frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session
Time frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session
Time frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session
Time frame: Baseline, one week after each session, and at 6 months
Time frame: Baseline, 6 months, and 3 weeks after the third session
Johns Hopkins University
Other
Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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