Trial-anchored psychedelic practice guidance

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.