CompletedNot applicable

Low-Income Group Psilocybin Assisted Therapy for Depression

NCT06372197 · LIGPATD · Matthew Hicks

Closed to entry

Status

Not accepting participants

Not applicable

Phase

Target enrolment

Study sites

1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Recruitment Feasibility
Measured over Beginning at study approval and funding through full enrollment, up to 18 months
Retention Feasibility
Measured over From participant enrollment through follow-up, up to 18 months
Acceptability
Measured over Assessed at the three month follow-up visit after completion of intervention
Preliminary Safety and Tolerability: incidence and severity of adverse events
Measured over Through study completion, up to 18 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: * Oregon resident - this is due to the use of telehealth services and licenses of the study clinicians and their scope of practice within the state. * Age 21 or older - Oregon Psilocybin Services Act sets the minimum eligible age of 21. * Income 200% or below the Federal Poverty Line - this is the criteria for Oregon Medicaid (OHP). * DSM-5 diagnosis of Major Depression Disorder. * Current engagement with psychotherapy - no less than six therapy sessions in the previous six months and an intention to continue seeing their therapist no less than once every two weeks during the study period. This is to ensure participants have adequate psychological support during the study period. Participants must be willing to sign a release of information allowing study clinicians to communicate with their therapists. * At least six months of stable housing history. * Able to attend all study events. * Able to read and speak fluent English. Exclusion Criteria: * A personal or family history of an immediate family member of schizophrenia, psychosis of any kind, mania, or hypomania. * A current prescription for lithium. * Active suicidal ideations or history of suicide attempts. Passive ideation, such as "I wouldn't mind if I never woke up again" is permissible. * Uncontrolled hypertension. * Any form of personality disorder.

Where

1 study site

Facility	City	Region	Country
National University of Natural Medicine	Portland	Oregon	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06372197 on ClinicalTrials.gov →

Last updated in the registry 2025-06-05. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Indication

Depression120

Recruiting in

Oregon7