A Phase 1 interventional study of psilocybin and Intensity of support for spiritual practice in Healthy, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-24.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science
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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligibility criteria for volunteers who will receive psilocybin
Inclusion Criteria:
Exclusion Criteria:
General medical exclusion criteria:
Psychiatric Exclusion Criteria:
First of 5 groups, as described in the protocol and to which volunteers are blinded
Drug: psilocybin · Behavioral: Intensity of support for spiritual practice · Behavioral: Number of sessions
Second of 5 groups, as described in the protocol and to which volunteers are blinded
Drug: psilocybin · Behavioral: Intensity of support for spiritual practice · Behavioral: Number of sessions
Third of 5 groups, as described in the protocol and to which volunteers are blinded
Drug: psilocybin · Behavioral: Intensity of support for spiritual practice · Behavioral: Number of sessions
Fourth of 5 groups, as described in the protocol and to which volunteers are blinded
Drug: psilocybin · Behavioral: Intensity of support for spiritual practice · Behavioral: Number of sessions
Fifth of 5 groups as described in the protocol and to which volunteers are blinded
Drug: psilocybin · Behavioral: Intensity of support for spiritual practice · Behavioral: Number of sessions
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
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
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University