Criterion 3: Eligibility and exclusion

Learning Objectives

By the end of this module, the trainee will be able to:

• State what an eligibility determination is and how it differs from the readiness read of Criterion 1 and the coexisting-conditions review of Criterion 2, while depending on both.
• Integrate psychological, social, physiological, and pharmacological findings into a single admission decision that is defensible on its written reasoning.
• Distinguish client-level eligibility from program-level fit, and recognize when a person appropriate for psychedelic work is not appropriate for a specific program.
• Describe how inclusion and exclusion criteria are constructed in the clinical trial literature, and use that structure as a model for a program's own written criteria.
• Identify the exclusions that recur across trials, and separate the ones grounded in a specific safety mechanism from the ones that reflect trial design rather than settled clinical necessity.
• Treat eligibility as time-dependent, and frame a not-yet decision as a sequenced path with concrete conditions rather than a rejection.
• Produce a documented eligibility determination with its rationale, its conditions, and its next steps.

Key Terms

Eligibility determination. The integrative decision about whether a specific person should be admitted to a specific program at a specific time, formed by synthesizing the readiness read (Criterion 1) and the coexisting-conditions review (Criterion 2) against the program's defined scope.

Inclusion criteria. The conditions a person must meet to be admitted, for example a qualifying diagnosis, an age range, or a demonstrated level of preparation. In the trial literature, these are specified in advance and applied consistently (Goodwin et al., 2022).

Exclusion criteria. The conditions that disqualify a person from admission, for example, a personal or first-degree family history of a primary psychotic disorder, or a clinically significant suicide risk. Trials specify these in advance to protect participants (Goodwin et al., 2022; Carhart-Harris et al., 2021).

Client-level eligibility. Whether a person is appropriate for psychedelic work at all, given their readiness and coexisting conditions.

Program-level fit. Whether this particular program, given its scope, medical capacity, and staffing, can safely hold this particular person. A person can clear client-level eligibility and still fail program-level fit.

Scope of the program. The defined range of clients, conditions, and situations a program is designed, staffed, and equipped to serve. Eligibility is meaningful only relative to a stated scope.

Sequenced deferral. A decision that a person is not eligible now but may become eligible after defined preparation or stabilization, paired with concrete conditions and a path back, rather than a permanent refusal.

Eligibility documentation. The written record of the determination, its rationale across all domains, any conditions attached, and the next steps, which provides continuity of care, transparency, and a defensible account of the decision.

Core Teaching

What an eligibility determination is

Criteria 1 and 2 gather information. Criterion 3 decides with it. Readiness screening reads a person across psychological, social, and physiological domains and their timing. The coexisting-conditions review detects the medical, psychiatric, and pharmacological factors that alter risk and routes them. Eligibility is the step that integrates both into a single answer to a single question: should this person be admitted to this program at this time? The determination is not a new assessment layered on top of the first two. It is the disciplined synthesis of what they found, weighed against what this program can actually hold.

The question has three parts, and each one can independently change the answer. Is this person appropriate for psychedelic work at all? Is this program the right container for them? Is now the right time? A person can pass the first and fail the second, or pass the first two and fail the third. Treating eligibility as a single yes or no, rather than as these three conjoined judgments, is the most common way the determination goes wrong.

Integrating the screening data

Eligibility is determined by synthesis, not by any one finding. A person with stable, well-supported depression and no interacting medications, who has protected time for integration, is a straightforward inclusion; depression is among the conditions in which supervised psychedelic therapy has shown benefit (Davis et al., 2021; Gukasyan et al., 2022). A person with untreated mania is a straightforward exclusion, because the serotonergic action of these compounds can precipitate or worsen mania (Johnson, Richards, & Griffiths, 2008). Most real determinations sit between these poles, where a strength in one domain has to be weighed against a caution in another. The facilitator's task is to hold the whole picture rather than fixate on a single variable, and to state in writing how the domains were weighed to reach the decision. A determination that cannot be defended on its written reasoning is not a determination; it is a preference.

How eligibility criteria are actually built: the trial model

Facilitators do not have to invent eligibility logic from scratch, because the clinical trials have already built and published it, and their structure is a usable model even for programs operating outside a research setting. Trials specify inclusion and exclusion criteria in advance and apply them consistently, which is what makes an eligibility decision auditable rather than arbitrary. The phase 2 trial of single-dose psilocybin for treatment-resistant depression, for example, enrolled adults with treatment-resistant depression and excluded, among others, people with a personal or first-degree family history of specified psychotic and bipolar-I conditions, current mania, and a clinically significant suicide risk (Goodwin et al., 2022). The trial comparing psilocybin with escitalopram used similar logic, excluding an immediate-family or personal history of psychosis, a history of serious suicide attempts, and medically significant conditions that a physician judged made a person unsuitable (Carhart-Harris et al., 2021).

The transferable lesson is structural. Good eligibility criteria are defined before the client arrives, written down, grounded where possible in a stated reason, and applied the same way to everyone. A program that decides eligibility case by case, without written criteria, invites both inconsistency and bias. Writing the criteria in advance is itself a safety practice, and drafting a program's inclusion and exclusion list is one of the core competencies this criterion trains.

Which exclusions are mechanism-grounded, and which are trial artifacts

Not every exclusion in a trial protocol reflects a settled clinical necessity, and an honest eligibility framework distinguishes the two. Some exclusions rest on a specific safety mechanism. The exclusion of a personal or first-degree history of a primary psychotic disorder rests on the mechanistic concern that 2A agonism can precipitate or worsen psychosis (Johnson, Richards, & Griffiths, 2008); this is a mechanism-grounded exclusion that a program should take seriously regardless of setting. The serotonergic-medication and cardiac exclusions taught in Criterion 2 are of the same kind, grounded in serotonin syndrome and QT-interval pharmacology.

Other exclusions reflect trial design more than universal clinical truth. Trials routinely exclude people to protect the internal validity of the study, to limit liability, or to reduce variance, and some of these boundaries are actively debated in the field. The exclusion of people with a family history of bipolar disorder, for instance, is standard across trials but has been argued to be broader than the evidence strictly requires, on the grounds that the category is common and heterogeneous and that a blanket exclusion may deny access to people who could be treated safely (see the ongoing debate in the psychedelic-therapy ethics literature). A facilitator should not import a trial's entire exclusion list as though every item carried the same weight. The discipline is to separate the exclusions that protect against a known harm from the ones that protected a study's design, and to build program criteria on the former while reasoning carefully about the latter.

Client-level eligibility versus program-level fit

A person can be appropriate for psychedelic therapy and still be wrong for a particular program. This distinction is where many eligibility errors live, because a facilitator who has concluded that a person is a good candidate can slide into assuming the person is a good candidate for their program specifically. A retreat without on-site medical support is not an appropriate container for someone with a complex cardiac history, even if that person is otherwise stable and well-prepared, because the program cannot hold the risk it would be taking on. The same person might be fully eligible for a medically supervised clinical program.

Program-level fit is a function of scope, medical capacity, staffing, and the specific compound involved. The compound matters because the required container differs by class: the ibogaine cardiac-monitoring requirement and the ayahuasca washout coordination taught in Criterion 2 are program-capacity questions as much as clinical ones. Determining eligibility therefore means knowing the honest limits of one's own program and being willing to refer a suitable person elsewhere when those limits are reached. Referring a good candidate to a better-matched program is not a failure of the determination; it is the determination working correctly.

Eligibility is time-dependent

Eligibility is dynamic rather than fixed, and this follows directly from the readiness logic of Criterion 1, where timing can override an otherwise clear profile. A person who is ineligible now because of acute stress, a recent substance relapse, or unstable housing may become eligible after stabilizing. The plasticity window taught in Criterion 1 sharpens the point: admitting someone in the middle of acute upheaval risks consolidating that upheaval rather than a resolution, which is a reason to wait even when every other domain is clear. A not-yet decision, framed as a sequence with concrete conditions and a genuine path back, is a clinical act rather than a rejection. In practice, people who are told not yet and given a way forward often return later better prepared, and the initial discernment turns out to have served them.

Documentation and the ethics of the decision

An eligibility determination that is not documented is incomplete because the record provides continuity, transparency, and a defensible account of the reasoning. The documentation should capture the readiness findings from Criterion 1, the coexisting-conditions review from Criterion 2, the integrated decision, any conditions attached to a deferral, and the referral destination where one applies. Beyond accountability, documentation disciplines the decision itself: a determination that has to be written down and defended is less likely to rest on an unexamined impression. This connects forward to Criterion 5, where the same information is formalized into the intake record, and it rests on the same scope-of-practice humility that anchors Criteria 1 and 2. Eligibility is where a program decides whom it can honestly hold, and doing that well protects the person, the group, and the integrity of the work.

Clinical and Decision Tools

Tool 1. The three eligibility questions

Every determination answers these three in order. A No at any level changes the outcome, and the tool records which level was decisive.

Tool 2. Eligibility integration grid

Bring each domain's read from Criteria 1 and 2 into one place, then state the integrated decision and the reasoning that connects them. This is the documented core of the determination.

Tool 3. Exclusion type reference

Sort any exclusion under consideration by its basis, so the program builds its criteria on mechanism-grounded exclusions and reasons carefully about design-based ones rather than importing a trial list wholesale. Shaded rows are mechanism-grounded hard exclusions in most settings.

Tool 4. Eligibility outcomes

Integrate the three questions and the grid into one of four documented outcomes.

Admit. Client-level eligible, program is an appropriate container, timing is adequate. Proceed to intake and preparation.

Admit with conditions. Fundamentally eligible, but one requirement must be met first, for example a prescriber-coordinated medication step from Criterion 2. Name the condition and the marker that satisfies it.

Defer (sequenced). Appropriate person, wrong time. Set concrete stabilization or preparation conditions and a path back.

Refer out. Either not client-level eligible, or eligible but a poor fit for this program's scope or capacity. Route warmly, with clear reasoning, to the appropriate professional or better-matched program.

Worked Examples: Completed Eligibility Determinations

The following models the reasoning and documentation this criterion should produce. Details are fictional.

Worked Example 1: Admit with conditions

Client: R.M., 42, treatment-resistant depression, seeking psilocybin work. Screening (Criterion 1) and coexisting-conditions review (Criterion 2) already completed.

Client-level eligibility: Psychological, social, and physiological reads all Proceed, with one Caution: a supervised SSRI washout is in progress. Depression is an indication for the work, not an exclusion (Davis et al., 2021; Gukasyan et al., 2022). No mechanism-grounded exclusion is present. Eligible at the client level.

Program fit: This is a medically supervised clinical program with prescriber coordination available, which matches this person's needs. Fit confirmed.

Timing: No acute stressor; integration window protected. Adequate.

Determination: Admit with conditions. The single condition is completion of the prescriber-supervised SSRI washout and confirmation of a stable baseline, per Criterion 2. Marker: prescriber confirms completed washout. Rationale documented and, with signed release, shared with the treating clinician.

Worked Example 2: Eligible person, wrong program

Client: K.S., 58, seeking psilocybin work for existential distress related to a cancer diagnosis, a context with trial support (Ross et al., 2016). Psychologically stable, well supported, strongly motivated.

Client-level eligibility: No psychiatric contraindication. However, the coexisting-conditions review found a significant cardiac history requiring monitoring. Client-level eligibility is plausible with the right medical container.

Program fit: The program in question is a non-clinical retreat with no on-site medical support or cardiac monitoring capability. This program cannot safely hold this person's cardiac risk, regardless of their psychological suitability.

Determination: Refer out on program-fit grounds. This person is likely eligible for a medically supervised program that can provide cardiac monitoring and clearance. Route warmly, with the reasoning stated plainly: the limitation is this program's capacity, not the person's suitability. Document the referral and rationale.

Case Vignettes

Work each vignette through the three eligibility questions and the integration grid, reach one of the four outcomes, and write one paragraph defending it. Fillable response sheets are in the companion worksheet PDF.

Vignette A

A well-supported, medically clear person with stable depression applies to a trauma-focused program. Their presenting issue is not trauma but a desire for personal growth and insight. They meet every safety criterion.

Guided questions: Which of the three eligibility questions is doing the work here? Is a safety-clear person automatically a program-fit? Is this an admit, a refer, or a conversation about the right container?

Vignette B

An applicant has no personal psychiatric history but reports that a parent has bipolar disorder. A program staff member wants to exclude them automatically, citing the trial exclusion lists.

Guided questions: Is a family history of bipolar disorder the same kind of exclusion as a personal or family history of a primary psychotic disorder? What distinguishes a mechanism-grounded exclusion from a contested trial-design one? How would you reason about this case without either dismissing the concern or applying a blanket rule?

Vignette C

A strong candidate on every domain reveals during screening that they are three weeks into an acrimonious divorce and a contested move. They are eager to proceed immediately, arguing the medicine will help them cope.

Guided questions: On the three questions, which one is not yet satisfied? How does the plasticity window from Criterion 1 bear on admitting someone mid-upheaval? How do you frame a deferral so it lands as sequencing rather than rejection?

Vignette D

A person with a qualifying diagnosis and strong readiness wants ibogaine treatment at a program that offers it but has no ECG capability, no continuous cardiac monitoring, and no on-site emergency response. The person is willing to sign any waiver.

Guided questions: Does the person's willingness to sign a waiver change the program-fit analysis? Which criterion supplies the safety requirement being violated? Is this an eligibility decision about the person or about the program, and what is the correct outcome?

Vignette E

An applicant clears client-level eligibility and program fit and timing. During the final review, staff realize the program has never written down its eligibility criteria and has been deciding case by case, with different facilitators reaching different conclusions on similar profiles.

Guided questions: What risk does the absence of written criteria create, beyond this one case? What does the trial model suggest the program should do? Is this applicant's determination trustworthy in the current system, and what would make it so?

Role-Play and Practice Scripts

Practice in pairs, then switch. The aim is to communicate an eligibility decision, including a difficult one, with clarity and without either false reassurance or a sense of judgment.

Explaining an admit-with-conditions decision

“You are a good fit for this work, and there is one thing we need to complete first before we begin. Your prescriber and I need to coordinate a medication step, for your safety. Once that is done and your baseline is stable, we move forward. I will document exactly what we are waiting on so it is clear to both of us.”

Delivering a program-fit referral

“This is not a question of whether you are suitable for this work; I believe you are. It is that this specific program cannot provide the medical support your situation calls for. I would be doing you a disservice to admit you here. Let me help you find a program that can hold this safely.” Practice separating the person’s suitability from the program’s limits so the referral does not read as rejection.

Reasoning through a contested exclusion aloud

“You mentioned a parent with bipolar disorder. I want to be honest about how I am thinking about that. A personal or family history of certain psychotic conditions is a firm safety line for us. A family history of bipolar disorder, without any personal history, is something the field genuinely debates, so I am not going to apply it as an automatic no. Let us look at your own history and stability carefully together.”

Framing a sequenced deferral

“Based on everything, I do not think now is the right time, and I want to be precise that this is about timing, not about you. Here is what I would want to see settle first, and here is how we stay in contact so that when the time is right, you are not starting over.”

Self-Assessment and Reflection

Knowledge check

1. State the three questions an eligibility determination must answer, and give an example of a person who passes the first and fails the second.
2. Explain how eligibility depends on Criteria 1 and 2 without being a repeat of either.
3. Describe how the clinical trials construct inclusion and exclusion criteria, and why writing criteria in advance is itself a safety practice.
4. Distinguish a mechanism-grounded exclusion from a trial-design one, with an example of each, and explain why a program should not import a trial's full exclusion list wholesale.
5. Explain why a person's willingness to sign a waiver does not resolve a program-fit problem.
6. Give a profile of someone who is client-level eligible, program-fit, but should still be deferred, and explain the reasoning.

Reflection

1. Does your program have written eligibility criteria applied consistently across facilitators? If not, that gap is both a safety and a fairness liability. What is your plan to close it?
2. Where are you most tempted to stretch program-fit for a person you like or want to help? What structure would hold that line?
3. Recall an eligibility decision, yours or one you observed, that turned out to be wrong in either direction. Which of the three questions was misjudged, and what would have caught it?

Summary

Criterion 3 is where screening becomes a decision. It integrates the readiness read of Criterion 1 and the coexisting-conditions review of Criterion 2 into a single, documented answer to whether a specific person should be admitted to a specific program at a specific time. That answer has three parts: client-level eligibility, program-level fit, and timing, and a No at any level changes the outcome. The clinical trials supply a usable model for how eligibility criteria are built: specified in advance, grounded in stated reasons, and applied consistently; they also teach a discipline of discernment, since some exclusions rest on a specific safety mechanism while others reflect trial design and remain contested. A person can be suitable for the work and wrong for a given program, and referring such a person elsewhere is the determination working rather than failing. Eligibility is time-dependent, so a not-yet decision framed as a sequenced path is a clinical act, not a rejection. Documented with its reasoning, the determination protects the person, the group, and the integrity of the program, and it carries forward into the intake record of Criterion 5.

References

Davis, A. K., Barrett, F. S., May, D. G., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., Finan, P. H., & Griffiths, R. R. (2021). Effects of psilocybin-assisted therapy on major depressive disorder: A randomized clinical trial. JAMA Psychiatry, 78(5), 481–489. https://doi.org/10.1001/jamapsychiatry.2020.3285

Johnson, M. W., Richards, W. A., & Griffiths, R. R. (2008). Human hallucinogen research: Guidelines for safety. Journal of Psychopharmacology, 22(6), 603–620. https://doi.org/10.1177/0269881108093587

Carhart-Harris, R., Giribaldi, B., Watts, R., Baker-Jones, M., Murphy-Beiner, A., Murphy, R., Martell, J., Blemings, A., Erritzoe, D., & Nutt, D. J. (2021). Trial of psilocybin versus escitalopram for depression. New England Journal of Medicine, 384(15), 1402–1411. https://doi.org/10.1056/NEJMoa2032994

Downey, A. E., Bradley, E. R., Lerche, A. S., O’Donovan, A., Krystal, A. D., & Woolley, J. (2024). A plea for nuance: Should people with a family history of bipolar disorder be excluded from clinical trials of psilocybin therapy? Psychedelic Medicine, 2(2), 61–73. https://doi.org/10.1089/psymed.2023.0051

Goodwin, G. M., Aaronson, S. T., Alvarez, O., Arden, P. C., Baker, A., Bennett, J. C., Bird, C., Blom, R. E., Brennan, C., Brusch, D., Burke, L., Campbell-Coker, K., Carhart-Harris, R., Cattell, J., Daniel, A., DeBattista, C., Dunlop, B. W., Eisen, K., Feifel, D., … Malievskaia, E. (2022). Single-dose psilocybin for a treatment-resistant episode of major depression. New England Journal of Medicine, 387(18), 1637–1648. https://doi.org/10.1056/NEJMoa2206443

Gukasyan, N., Davis, A. K., Barrett, F. S., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., & Griffiths, R. R. (2022). Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Journal of Psychopharmacology, 36(2), 151–158. https://doi.org/10.1177/02698811211073759

Ross, S., Bossis, A., Guss, J., Agin-Liebes, G., Malone, T., Cohen, B., Mennenga, S. E., Belser, A., Kalliontzi, K., Babb, J., Su, Z., Corby, P., & Schmidt, B. L. (2016). Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial. Journal of Psychopharmacology, 30(12), 1165–1180. https://doi.org/10.1177/0269881116675512