An interventional study of Psilocybin in Depression, sponsored by Matthew Hicks. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Matthew Hicks · Not applicable, Interventional, and Treatment
Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population.
Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), Hamilton Depression Inventory, PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview.
Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment.
The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 20 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Matthew Hicks as lead sponsor.
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Exclusion Criteria:
This is an uncontrolled feasibility study with only one arm.
Drug: Psilocybin
Following Oregon Psilocybin Services (OPS) rules, participants will be placed in cohorts of five to six, which whom they will do two 90-minute preparation session, two psilocybin sessions, and two 90-minute integration sessions. All sessions will be guided by two licensed facilitators.
Recruitment Feasibility
Determine the recruitment rate (number of participants enrolled compared to those approached) for low-income adults with depression into a group psilocybin-assisted therapy program.
Time frame: Beginning at study approval and funding through full enrollment, up to 18 months
Retention Feasibility
Evaluate the participant retention rate throughout the study, including psilocybin sessions and follow-up assessments.
Time frame: From participant enrollment through follow-up, up to 18 months
Acceptability
Assess participant satisfaction with the group psilocybin-assisted therapy format through qualitative interviews and survey, including "On a scale of 0 to 5, zero being very dissatisfied and 5 being very satisfied, how would you rate your satisfaction with the treatment overall?"
Time frame: Assessed at the three month follow-up visit after completion of intervention
Preliminary Safety and Tolerability: incidence and severity of adverse events
The incidence and severity of adverse events associated with psilocybin administration in a group setting will be documented and reported on to assess safety and tolerability.
Time frame: Through study completion, up to 18 months
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System provides metrics for seven health related domains including depression.
Time frame: Baseline (enrollment), integration #1 (3rd week of treatment), integration #2 (4th week of treatment), and follow-up (3 months post-treatment)
Altered State of Consciousness rating scale (11-ASC)
Provides a rating of intensity of altered state experiences across eleven domains.
Time frame: At the end of both psilocybin sessions (week 3 and week 4).
Hamilton Depression Inventory
Provides a rating of depressive symptoms across several subdomains.
Time frame: Baseline (enrollment), integration #1 (3rd week of treatment), integration #2 (4th week of treatment), and follow-up (3 months post-treatment)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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