Psilocybin for Depression
(LIGPATD Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByMatthew R Hicks, ND, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Matthew Hicks

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults in Oregon with incomes at or below 200% of the federal poverty level, diagnosed with major depression. Participants must be over 21, have stable housing for six months, attend all study events, and be engaged in ongoing psychotherapy. They cannot join if they don't meet these criteria.

Inclusion Criteria

I have been diagnosed with Major Depression Disorder.

Able to read and speak fluent English

Income 200% or below the Federal Poverty Line - this is the criteria for Oregon Medicaid (OHP)

+5 more

Exclusion Criteria

Active suicidal ideations or history of suicide attempts. Passive ideation, such as 'I wouldn't mind if I never woke up again' is permissible

I am currently prescribed lithium.

Any form of personality disorder

+2 more

Participant Groups

The trial tests psilocybin-assisted group therapy's feasibility for treating depression among low-income individuals. It includes medical screening, questionnaires, two preparation sessions, two psilocybin sessions, two integration sessions and a follow-up after three months.

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

This is an uncontrolled feasibility study with only one arm.