Trial-anchored psychedelic practice guidance

Preview competencies (3)

• Psychiatric assessment

  Administer and interpret protocol-specified psychiatric assessments across screening, baseline, post-dose, and follow-up time points.

• Assessment-instrument knowledge

  Understand the purpose, structure, scoring, and administration timing of the protocol's psychiatric and cognitive instruments.

• Informed consent and participant orientation

  Ensure that candidate participants complete informed consent before study procedures and understand relevant study expectations, procedures, and avenues for support.

Preview competencies (3)

• Presence during altered state

  Remain with the patient during the altered state of consciousness after dosing to provide containment, support, and safety monitoring. This is a core facilitation responsibility during the dosing session.

• Psychedelic research safety practices

  Apply established safety practices specific to psychedelic research throughout treatment. The facilitator must support safe administration, monitoring, and discharge readiness.

• Discharge readiness assessment

  Assess whether the patient is ready for discharge after dosing using the structured readiness questionnaire. This is a safety gate before the patient leaves the clinic.

Preview competencies (3)

• Accurate source limitation recognition

  Ability to acknowledge when the source does not contain therapist or facilitator competency information. The extractor should not overstate what can be supported by the text.

• Clinical trial record interpretation

  Ability to understand and use information from a ClinicalTrials.gov study record. This includes recognizing that the source text is a study registry record and not a clinical practice guideline.

• Study record compliance awareness

  Awareness of registry submission and data element requirements relevant to study record managers. This reflects procedural compliance rather than clinical safety, but is necessary for correct handling of trial information.

Preview competencies (3)

• Alcohol use disorder relapse prevention psychotherapy

  Deliver structured relapse prevention psychotherapy adapted for moderate to severe AUD. The therapist uses cognitive-behavioural and motivational strategies to address triggers, cravings, high-risk situations, and recovery planning.

• Suicide risk recognition and response

  Identify and respond to suicidal ideation, suicidal behaviour, and self-harm risk across screening, dosing, and follow-up. Significant suicidality is a special safety concern and may require exclusion, urgent assessment, or reporting.

• Confidentiality and data protection

  Protect participant privacy and maintain strict confidentiality of records, audio/video recordings, and study-related information. This includes limiting access and ensuring correct identification practices.

Preview competencies (3)

• TRD diagnostic and eligibility assessment

  Competently assess whether a participant meets diagnostic and treatment-resistance criteria for major depressive disorder without psychotic features and determine clinical suitability for psychedelic treatment.

• Psychiatric risk and exclusion screening

  Screen for psychiatric vulnerabilities and safety risks that may contraindicate psychedelic administration or require exclusion, additional evaluation, or referral.

• Informed consent and participant preparation

  Provide standardized informed consent and preparation that enables participants to understand the investigational treatment, procedures, possible experiences, risks, and follow-up requirements.

Preview competencies (3)

• Informed consent and preparation

  Provide clear, accurate preparation and obtain written informed consent before participation, while explaining the intervention, expected subjective effects, duration, procedures, and potential adverse events.

• Dose-escalation decision-making

  Apply individualized dose-escalation procedures only after evaluating safety and the participant's experience, and obtain participant consultation and consent before additional dosing.

• Ethical and regulatory compliance

  Conduct facilitation within approved research, ethical, and regulatory frameworks, prioritizing participant welfare, autonomy, scientific integrity, and risk minimization.

Preview competencies (3)

• Qualified clinical practice

  Maintain the education, training, experience, and clinical competence required to conduct participant-facing procedures and make appropriate medical decisions.

• Good Clinical Practice compliance

  Conduct all participant work in accordance with the approved protocol, ICH GCP, applicable regulations, ethical principles, and local legal requirements.

• Participant screening and eligibility assessment

  Accurately assess whether potential participants meet inclusion and exclusion criteria before performing study procedures or randomization.

Preview competencies (3)

• Clinical eligibility assessment

  Assess whether prospective participants meet diagnostic, severity, treatment-resistance, and study suitability criteria before psychedelic administration.

• Psychiatric contraindication screening

  Recognize psychiatric conditions and risk factors that may increase the likelihood of harm or invalidate participation.

• Informed consent

  Provide and document informed consent before participation, including relevant information about the intervention, procedures, risks, and alternatives.

Preview competencies (3)

• Psychedelic therapy training

  Therapists should have specific knowledge of psychedelic compounds, psychedelic research safety practices, and the psychological effects of altered states of consciousness.

• Alcohol use disorder expertise

  AUD therapists must understand moderate-to-severe AUD, alcohol withdrawal, craving, relapse mechanisms, and evidence-based relapse-prevention treatment.

• Therapeutic alliance building

  Facilitators are expected to establish and maintain rapport and a therapeutic alliance before dosing so that participants feel prepared, safe, and able to engage in ongoing therapy.

Preview competencies (0)

Competency extraction pending.

Preview competencies (3)

• Psychedelic trial participant suitability screening

  Ability to determine whether a participant meets diagnostic, severity, and treatment-resistance criteria for entry into a psychedelic depression study. This includes confirming the target disorder, current episode validity, and adequacy of prior treatments.

• Administration of vaporized 5-MeO-DMT

  Ability to correctly deliver the investigational inhaled drug using standardized vaporization procedures and participant instructions. Safe and accurate administration is central to the dosing protocol.

• Safety monitoring of acute psychiatric effects

  Ability to monitor for acute psychiatric adverse effects during and after dosing, including anxiety, flashbacks, dissociation, and suicidality. This is a core facilitator/therapist responsibility in psychedelic studies.

Preview competencies (1)

• Source access blocked

  The provided source text does not contain the guideline content; it only shows a browser/reCAPTCHA access check. No therapist/facilitator competencies can be reliably extracted from the supplied text.

Preview competencies (0)

Competency extraction pending.

Preview competencies (1)

• Source inaccessible

  The provided source text does not contain the guideline content needed to extract therapist/facilitator competencies. It only shows an access error message from the webpage.

Preview competencies (3)

• Use of standardized outcome measures

  Understands and applies validated questionnaires for psychedelic research and clinical assessment. Competence includes selecting, administering, and interpreting measures of subjective experience and related outcomes.

• Psychological state assessment

  Evaluates the participant’s subjective psychedelic experience using structured measures of peak, mystical, ego-dissolution, challenging, and altered-state phenomena. This requires sensitivity to both positive and difficult experiential states.

• Psychedelic administration protocol adherence

  Can administer a novel vaporized psychedelic formulation using a structured study protocol, including single-dose and individualized dose-escalation regimens. The facilitator must follow dosing procedures precisely to support safety and interpretability of effects.

Preview competencies (3)

• Ethical and regulatory compliance

  Conduct the work in accordance with applicable ethical and clinical research standards. Compliance with protocol, GCP, and Helsinki principles is required.

• Informed consent facilitation

  Ensure written informed consent is obtained before any trial-related procedure and that participation is voluntary and informed. The facilitator must respect participant autonomy throughout the process.

• Psychedelic preparation and rapport-building

  Provide pre-dose preparation that educates participants about the drug experience and establishes trust with the monitor. Preparation is used to improve psychological readiness and reduce distress during dosing.

Preview competencies (3)

• TRD eligibility assessment

  Understands and applies study criteria to determine whether a participant meets treatment-resistant depression (TRD) requirements. This includes confirming diagnostic and treatment-history thresholds before dosing.

• Psychiatric adverse event monitoring

  Continuously assesses for emergent psychiatric symptoms that could indicate harm from dosing. Psychiatric monitoring is central because the intervention can acutely alter perception, thought, and affect.

• Informed consent and participant preparation

  Ensures participants understand the study, the active nature of dosing, and the limits of the therapeutic model. Preparation is framed as standard medical care and supportive readiness rather than formal psychotherapy.

Preview competencies (3)

• Double-blind trial conduct

  Maintains methodological integrity by preventing bias and protecting the validity of outcomes. The facilitator must preserve the blind and avoid influencing participant expectations or reporting.

• Participant safety monitoring

  Monitors participants for adverse effects and tolerability during and after dosing. Recognizes that mild events such as nausea and headache may occur and ensures they are transient and self-resolving or escalated if needed.

• Clinical research compliance

  Operates within a Phase I clinical trial framework and follows regulatory, protocol, and registration requirements. Ethical conduct includes accurate documentation and adherence to approved study procedures.

Preview competencies (1)

• Protocol and registration literacy

  Understand the clinical trial record context and the information structure used to describe a study. This supports accurate interpretation of the study’s stated methods and requirements.

Preview competencies (1)

• Clinical trial record interpretation

  Understands how to read and interpret a ClinicalTrials.gov study record and related registration information. This supports extracting protocol-relevant expectations for therapist or facilitator roles when the source is limited to registry metadata.

Preview competencies (3)

• General psychedelic-assisted practice skills

  Two trained study personnel must be present during dosing, and they must be able to support and monitor the patient throughout the acute experience. The lead monitor and assistant monitor require specific clinical qualifications and training relevant to psychedelic administration.

• Acute psychological response and emergency management during dosing

  The facilitator must actively monitor physiological and psychiatric safety during dosing and after each dose. This includes frequent vital signs, oxygenation, sedation, dissociation, psychosis-like symptoms, and discharge readiness.

• General psychedelic-assisted practice skills

  The therapist/facilitator must ensure informed consent is obtained before any protocol procedures and that the patient understands the dosing experience and trial expectations. Preparation includes explaining the procedure, expected psychoactive effects, and how to approach the experience without psychological resistance.

Preview competencies (3)

• Adverse event recognition and reporting

  The facilitator must identify and report adverse events throughout treatment. This is a core safety responsibility in the source’s study procedures.

• Suicidality evaluation and monitoring

  The facilitator must assess suicidal ideation and monitor for changes before and after intervention. The source emphasizes specific suicidality instruments used in the study context.

• Vital signs monitoring

  The facilitator should monitor physiological safety during and after administration. The source explicitly lists vital signs as part of safety-related measures.

Preview competencies (3)

• Data element compliance awareness

  Understands the obligation to follow defined data element standards when submitting or interpreting study information. This is relevant to accurate, non-misleading representation of therapist/facilitator qualifications.

• Clinical trial record navigation

  Understands how to interpret and use ClinicalTrials.gov study records and supporting glossary/definitions. This supports accurate extraction of protocol-relevant therapist or facilitator requirements.

• Protocol-specific competency identification

  Can determine whether a study record actually specifies therapist/facilitator responsibilities or competencies. This includes distinguishing direct treatment skills from administrative registry instructions.

Preview competencies (1)

• Source limitation awareness

  The provided source text contains only ClinicalTrials.gov interface text and no protocol content describing therapist or facilitator requirements. No substantive competencies can be extracted from the available text.

Preview competencies (3)

• Protocol and registry navigation

  The therapist/facilitator should be able to locate and interpret study information in the ClinicalTrials.gov record and related registry materials. This supports understanding of the study context, procedural expectations, and administrative requirements.

• Study documentation interpretation

  The facilitator should understand how study record managers use data element definitions for submission of registration or results information. This reflects basic familiarity with clinical trial documentation standards.

• Administrative compliance awareness

  The facilitator should follow appropriate administrative and reporting conventions associated with clinical trial records. Even from limited source text, this implies attention to correct and responsible handling of study information.

Preview competencies (3)

• Psychedelic therapy preparation

  Provide structured psychological preparation before intranasal 5-MeO-DMT treatment. Preparation is delivered through standardized sessions by a trained therapist.

• Nondirective therapeutic support

  Provide psychological support in a standardized, nondirective manner before, during, and after dosing. Avoid directing or attempting to control the participant's experience.

• Post-session integration

  Conduct structured, nondirective psychological integration after dosing to help participants reflect on and process the treatment experience.

Preview competencies (3)

• Safety-oriented monitoring of acute reactions

  Facilitators must monitor for acute adverse effects during the 5-MeO-DMT experience. The review identifies both psychological and physical reactions that can occur rapidly and may require observation or intervention.

• Ethical sourcing and ecological responsibility

  The review explicitly discourages clinical development based on toad venom because of ethical and ecological concerns. Facilitators should favor synthetic sources and avoid practices that could harm wildlife or ecosystems.

• Set and setting preparation

  Facilitators should prepare the participant’s mindset and environment to optimize safety and therapeutic response. The guideline emphasizes realistic expectations, trusted support, and minimizing distractions before administration.

Preview competencies (3)

• Health screening and risk assessment

  Facilitators should screen participants for physical, mental, and medical contraindications before participation. Screening is intended to identify risks and determine whether participation is appropriate on a case-by-case basis.

• Confidential intake and privacy protection

  Participant information must be treated as private and confidential throughout intake, screening, and follow-up. Facilitators are expected to protect sensitive data and session details.

• Clear communication and informed orientation

  The facilitator should provide clear, comprehensible information about the process, expectations, restrictions, and support available. Communication may occur in writing, by phone, email, or structured orientation.