DepressionLIGPATDNCT06372197
Low-Income Group Psilocybin Assisted Therapy for Depression
A study testing Psilocybin in people with Depression, run by Matthew Hicks at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 14 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Natural Medicine
Portland, Oregon, 97201
About this study
Official title: Low-Income Group Psilocybin Assisted Therapy for Depression: A Feasibility Study
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.
Read more
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.
- Conditions
- Depression
- Being tested
- Psilocybin
- Keywords
- poverty, low-income, psychedelics, psilocybin
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is an uncontrolled feasibility study with only one arm. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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?"
Measured: 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.
Measured: Through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Aug 2024
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Hicks
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Hicks, National University of Natural Medicine
- Investigators
- Matthew R Hicks, ND, MS, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372197
- Sponsor's protocol ID
- LIGPATD
- Acronym
- LIGPATD
- Status last verified
- Jun 2025
- First submitted
- 10 Apr 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Income Group Psilocybin Assisted Therapy for Depression: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06372197
- Acronym / sponsor ID
- LIGPATD / LIGPATD
- Conditions
- Depression
- Keywords
- poverty, low-income, psychedelics, psilocybin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Matthew HicksUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: PsilocybinThis is an uncontrolled feasibility study with only one arm. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinFollowing 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. | Drug | Intervention |
Primary outcome
Recruitment Feasibility
Time frame: Beginning at study approval and funding through full enrollment, up to 18 months
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.
Retention Feasibility
Time frame: From participant enrollment through follow-up, up to 18 months
Evaluate the participant retention rate throughout the study, including psilocybin sessions and follow-up assessments.
Acceptability
Time frame: Assessed at the three month follow-up visit after completion of intervention
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?"
Preliminary Safety and Tolerability: incidence and severity of adverse events
Time frame: Through study completion, up to 18 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew R Hicks, ND, MS principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psilocybin in people with Depression, run by Matthew Hicks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Beginning at study approval and funding through full enrollment, up to 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.