Dosing

Teaches how to obtain and maintain valid informed consent through clear disclosure, comprehension checks, capacity support, voluntariness, non-coercion, and respect for refusal or withdrawal. The competency also covers consent for screening procedures, recordings, collateral contact, rescue interventions, and documentation of the consent process.

Cluster covering 31 related competencies including: Integration support, Integration therapy, Integration coaching.

Teaches protection of participant identity, sensitive clinical or occupational information, recordings, and research data. The competency covers coded identifiers, restricted access, secure handling, confidentiality safeguards, and privacy-preserving documentation.

Cluster covering 35 related competencies for monitoring acute psychological effects, recognising and managing distress, crisis containment, emergency escalation, and rescue-medication coordination during psychedelic dosing sessions.

Teaches how to detect, elicit, document, and report adverse events and serious adverse events across the participant journey. The focus is accurate source documentation, regulatory reporting discipline, follow-up, and preservation of participant safety and trial integrity.

Teaches structured assessment of suicidal ideation, intent, psychiatric deterioration, and related high-risk presentations. Learners are trained to use appropriate tools, safety planning, emergency contacts, clinician access, and escalation pathways when risk is identified.

Teaches how to assess clinical suitability before psychedelic or ketamine treatment, including medical and psychiatric screening, readiness evaluation, contraindication review, inclusion/exclusion criteria, and ongoing eligibility re-checks before dosing.

Teaches faithful delivery of manualized treatment and protocol-defined procedures while documenting and managing unavoidable deviations. The competency protects participant welfare, treatment consistency, data integrity, and sponsor oversight.

Teaches ongoing participant contact after dosing to support stability, detect delayed adverse effects, maintain therapeutic containment, and sustain adherence to follow-up visits and outcome assessments.

Teaches recognition of medical or psychiatric emergencies and the steps required to escalate care safely. The competency includes de-escalation, clinical consultation, 911 or emergency department transfer, serious-event escalation, and referral to appropriate higher-level care.

Teaches how to determine when a participant is safe to leave after dosing and how to arrange appropriate supervision afterward. The competency covers psychological and physical stability, escort/support-person coordination, discharge restrictions, overnight or post-session support, and follow-up contact when needed.

Teaches review and management of concomitant medications, restricted therapies, prohibited substances, washout periods, tapering requirements, and abstinence expectations. The competency includes participant counseling, medication reconciliation, sponsor notification, and team coordination when restrictions affect safety or interpretability.

Teaches delivery of psychedelic-assisted psychotherapy according to an approved study manual across preparation, dosing, integration, and follow-up. The competency balances standardized structure with non-directive support for the participant’s therapeutic process.

Teaches accurate study documentation, source-record quality, secure data capture, Good Clinical Practice recordkeeping, IRB and sponsor documentation requirements, monitoring readiness, audit support, accountability, and retention obligations.

Teaches how to preserve blinded trial conduct across participant interactions, outcome collection, staff roles, and session procedures. The competency includes preventing accidental unblinding, minimizing bias, and using emergency unblinding only when clinically necessary.

Teaches coordinated practice across co-therapists, physicians, psychiatrists, study coordinators, principal investigators, and other care-team members. The focus is shared responsibility, clear communication, role clarity, and coordinated observation of participant status.

Teaches adherence to Good Clinical Practice, assigned study roles, protocol procedures, delegation boundaries, and applicable research regulations. The competency supports consistent execution of approved procedures across sites and participants.

Cluster covering 2 related competencies including: Therapeutic alliance building, Therapeutic alliance and rapport building.

Teaches how to maintain clear relational and physical boundaries in emotionally vulnerable treatment settings. This includes professional conduct, rapport without overreach, explicit consent for touch, the right to revoke consent, and strict prohibition of sexual or erotic contact.

Teaches continuous monitoring for distress, confusion, psychotic symptoms, suicidality, agitation, and other acute behavioral risks during and after dosing. The focus is early recognition, documentation, and escalation to clinical support when risk emerges.

Cluster covering 3 related competencies including: Physical safety monitoring, Safety monitoring during dosing sessions, Medical safety monitoring during psilocybin administration.

Provides supportive therapeutic presence while the patient is under the influence of ketamine. Uses calming, noncoercive guidance to help the patient navigate dissociation and emotional material.

Cluster covering 11 related competencies including: Preparation support, Psilocybin preparation, Therapeutic preparation.

Teaches structured pre-dose preparation and post-dose integration as the therapeutic frame for psychedelic-assisted psychotherapy. The therapist supports rapport, intention clarification, meaning-making, emotional processing, and consolidation of insights after dosing.

Able to practice ethically in a clinical trial environment involving a Schedule-sensitive psychoactive intervention. This includes protecting participants, adhering to protocol, and supporting valid informed participation.

Teaches monitoring and response for acute physiological risks, including vital signs, temperature, hydration, overheating, excessive fluid intake, and suspected overdose. The competency emphasizes supportive care, medical coordination, documentation, and escalation when needed.

Ability to perform or supervise detailed psychiatric evaluation for diagnosis, eligibility, and ongoing monitoring. The therapist/facilitator must understand symptom presentations relevant to MDD, AUD, suicidality, psychosis, and dissociation.

Know the medical and psychiatric exclusions that protect participants from foreseeable harm. Facilitators must recognize conditions that make MDMA-assisted psychotherapy unsafe or inappropriate.

Cluster covering 6 related competencies including: Therapeutic support during dosing, Nondirective dosing-session presence, Supportive dosing-session facilitation.

Teaches recognition and management of expected and unexpected side effects during psychedelic or ketamine treatment. The competency emphasizes active observation, supportive response, and clinical escalation when symptoms exceed routine tolerability.

Cluster covering 9 related competencies including: Psilocybin facilitation, Psilocybin session support, Psilocybin facilitation basics.

Therapists must facilitate rather than control the participant's process, using invitations and timing interventions carefully. They should preserve the participant-led unfolding of experience while knowing when gentle direction or safety-based assertiveness is needed.

Teaches practices that support preparation and therapeutic presence, including mindfulness, intention-setting, body-aware attention, environmental preparation, mindset awareness, and regulation through somatic presence.

Cluster covering 7 related competencies including: Physiologic safety awareness, Hallucinogen pharmacology and effects, Hallucinogen-assisted therapy knowledge.

The protocol requires active monitoring for psychedelic-specific adverse events such as hallucinations, psychotic symptoms, dissociation, mood alteration, and cognitive disturbance. These require immediate notification and follow-up.

Cluster covering 12 related competencies including: KAP psychotherapy delivery, Ketamine and KAP knowledge, Ketamine integration planning.

Teaches structured monitoring of depressive symptoms, response, and remission across treatment and follow-up. Learners use standardized scales and clinical review to track change and identify deterioration or non-response.

The therapist/facilitator must support structured dose escalation decisions within the individualized dosing regimen. Decisions depend on both patient-reported peak experience and clinical tolerability/safety judgments.

Clinicians and research staff must clearly educate participants about study procedures, risks, side effects, restrictions, and possible benefits, and obtain written informed consent before screening and study participation. Ethical delivery depends on transparent communication and opportunities for questions.

Teaches how clinicians determine whether a participant should proceed, pause, discontinue dosing, or terminate study participation. The competency centers on safety-driven clinical judgment, risk-benefit assessment, and early termination when continuation is no longer appropriate.

Teaches recognition and documentation of dissociation, psychosis-like symptoms, mania, and other acute neuropsychiatric effects that can occur after ketamine, psychedelic dosing, or related interventions. The focus is monitoring, reporting, and escalation when symptoms become clinically significant.

Teaches how to instruct participants on post-dose and study-period restrictions that reduce risk from impaired judgment, unsafe activity, prohibited substances, or behaviors that could confound study outcomes.

Cluster covering 2 related competencies including: Psychedelic-assisted therapy facilitation, Group facilitation in a psychedelic setting.

Teaches culturally responsive psychedelic care, including humility, anti-bias practice, Indigenous and traditional-use awareness, cultural appropriation concerns, diversity and inclusion, and respectful work with marginalized communities.

Therapists must be able to teach and coach grounding practices that help participants regulate during preparation and dosing. These methods are used before medication and during distress.

Teaches clinicians and research staff to understand the purpose, limits, scoring, interpretation, and clinical meaning of psychological measures and study instruments used to evaluate symptoms, functioning, safety, and treatment outcomes.

Understand the pharmacology and interaction risks of 5-MeO-DMT/BPL-003, including serotonergic and cardiovascular concerns. This knowledge informs safe preparation, exclusion screening, and monitoring.

Teaches a trauma-informed stance during psychedelic work, including calm presence, non-verbal reassurance, body-aware support, somatic orientation, and containment through difficult experiences while maintaining safety and boundaries.

The study used standardized anxiety measures and followed patients for 2 months and 12 months, implying competence in tracking outcomes over time. Therapists should be able to assess symptom change and sustained benefit using structured follow-up.

Cluster covering 2 related competencies including: Medical escalation and rescue medication use, Medical escalation and rescue medication coordination.

Cluster covering 4 related competencies including: Therapeutic rapport building, Rapport building and trust development, Therapeutic rapport and trust building.

Teaches structured clinical interviewing and assessment administration for PTSD and related symptom domains, including symptom severity, functional impairment, risk factors, and appropriate use of standardized assessment tools.

Teaches counseling and monitoring around contraception, reproductive restrictions, pregnancy risk, and pregnancy-related discontinuation rules. Learners are trained to explain requirements clearly and respond promptly when pregnancy or reproductive-safety concerns arise.

Monitors participant physical status during study visits and identifies concerning changes requiring escalation. Vital signs and symptomatic changes are part of routine safety observation.

Cluster covering 4 related competencies including: Psychedelic therapy workflow, Psilocybin psychotherapy framework, Psilocybin-assisted psychotherapy framework.

Teaches continuous evaluation of clinical risk and maintenance of a safe care environment throughout preparation, dosing, and follow-up. Learners monitor risk signals, apply safety procedures, and escalate care when needed.

Teaches providers to create and maintain a psychologically and physically safe therapeutic setting through clear structure, preparation, boundaries, attunement, environmental design, and ongoing attention to participant safety.

Ability to administer and interpret structured interviews, clinician ratings, and self-report measures used in the study. Therapists contribute to eligibility, safety, and outcome assessment.

Facilitators must be able to contain and support intense psychological distress during the session. The study notes that the experience could be emotionally difficult even when participants felt safe.

Therapists/investigators must understand the medical suitability requirements for LSD-assisted psychotherapy and coordinate medication washout and concomitant medication review. This includes recognizing drug-drug interaction risks and contraindications.

Prepare participants for the dosing session and guide them through standardized procedures. The facilitator should ensure readiness, adherence to study rules, and smooth progression through the session schedule.

Therapists must ensure continuity of care after the acute session, including overnight observation and next-morning integration before discharge. This reflects a containment and recovery responsibility beyond the dosing period.

Therapists/facilitators must know the psychiatric and medical conditions that make KPT unsafe or inappropriate. Safe practice depends on excluding high-risk individuals.

Knows when to involve physicians, psychologists, and independent safety oversight. Complex psychedelic sessions require clear escalation pathways and team coordination.

Monitor and respond to the expected sympathomimetic effects of MDMA. The therapist/facilitator must be alert to transient increases in blood pressure, pulse, and related cardiac symptoms.

Cluster covering 2 related competencies including: Preparation of set and setting, Client preparation and therapeutic set/setting.

The training includes appropriate use of therapeutic touch as part of safe delivery. Learners are expected to use touch judiciously and within ethical boundaries.

The framework implies competence in evaluating both symptom change and subjective outcomes over time. The study used standardized anxiety measures and qualitative interviews to assess sustained effects and patient-reported change.

Cluster covering 2 related competencies including: Safety monitoring during ketamine dosing, Physiologic monitoring during ketamine administration.

Therapists should accurately represent the current evidence base and avoid overstating efficacy or durability. The article notes significant short-term benefit but also the need for larger multicenter trials and longer follow-up.

Understand the characteristic acute experiential domains elicited by ayahuasca. This includes perceptual, somatic, cognitive, affective, mystical, and temporal-spatial alterations.

Administer and interpret psychological and psychometric measures relevant to mood, cravings, expectations, mystical experience, ego dissolution, and functioning. Facilitators must accurately support questionnaire-based assessment across time points.

Therapists and facilitators should communicate treatment effects responsibly and acknowledge methodological limitations. The paper notes small sample size, lack of long-term control group, and need for further study of mechanisms.

Provide a calm and supportive environment during treatment to reduce distress and support tolerance of the experience. The case report notes food, rest, and a quiet place as part of care.

Create an environment that supports safety, comfort, and relaxation during the session. The setting is deliberately structured to reduce anxiety and facilitate a positive experience.

Ability to evaluate alcohol and other substance use patterns using standardized tools and clinical interview. This is essential for eligibility, safety, and outcome monitoring.

Teaches recognition and management of relational dynamics that can intensify in psychedelic-assisted therapy. Learners develop self-awareness around countertransference, projection, attachment, dependency, and other therapeutic-process risks.

Cluster covering 3 related competencies including: Ethical psychedelic facilitation, Safe, legal psychedelic care facilitation, Ethical decision-making in psychedelic facilitation.

Cluster covering 5 related competencies including: Concomitant medication review, Contraindication and interaction awareness, Contraindications, drug effects, and interactions.

The page signals training in managing difficult or high-risk moments, including crisis intervention and trigger management. Learners are expected to respond appropriately when a session becomes destabilizing or unsafe.

Where co-therapy is used, therapists should work cohesively, remain present, and respect participant preferences within the dyad.

The therapist is responsible for giving truthful, individualized preparation and reassurance about the experience, including likely sensations, risks of resistance, and expectations for conduct. The preparation aims to reduce fear, improve cooperation, and support voluntary participation.

Cluster covering 4 related competencies including: Integration and debriefing, Integration and debriefing facilitation, Integration and post-session debriefing.

Facilitators must understand the expected psychological, physiological, and potential adverse effects of MDMA in order to prepare participants, support the session, and detect complications.

Conduct preparatory sessions that orient the subject, assess readiness, and set expectations for MDMA-assisted psychotherapy. These sessions are used to prepare for safety, adherence, and therapeutic engagement.

Therapists may record sessions only with explicit participant consent and must handle recordings for training and research within protocol limits. Recording is part of the therapeutic and scientific framework, not routine clinical use.

Administer study measures and structured assessments on schedule, including psychological, spiritual, and neurobehavioral instruments. This includes both paper-based and Storyline-based assessments.

Ability to provide a consistent, supportive therapeutic environment during intensive psychedelic-assisted sessions. The facilitation role depends on maintaining trust and emotional safety.

The facilitator should know how oral and intravenous dosing relate to onset, duration, and peak effects. This knowledge supports proper session planning, monitoring, and integration timing.

Understands that MDMA is a Schedule 1 investigational product and must be stored, dispensed, and accounted for under regulatory control. Supports compliant handling during the session.

Therapists/facilitators should be able to judge whether therapeutic change reaches clinically meaningful thresholds, not just whether symptoms improve numerically. This supports informed ongoing care and communication about benefits and limitations.

The facilitator must administer and coordinate patient-rated and clinician-rated measures while minimizing bias. Assessments should be completed independently and in the correct order.

Cluster covering 5 related competencies including: Cardiac safety monitoring, Ketamine infusion monitoring, Ketamine infusion administration.

Understand the basic pharmacology and clinical effects of ayahuasca to inform safe facilitation and interpretation of responses. The source identifies dimethyltryptamine as a 5-HT2A agonist and harmine as a monoamine-oxidase A inhibitor.

Teaches monitoring during down-titration or discontinuation of psychiatric medications before dosing. Learners track withdrawal symptoms, symptom worsening, suicidality, and other risks that may emerge during tapering.

Therapists must be able to elicit a full account of the dosing experience without overinterpreting it. The goal is to help participants remember, narrate, and reflect on their experience in detail.

Can identify and involve support persons, attendants, and outside providers to enhance safety. The facilitator must coordinate practical supports while respecting confidentiality and protocol boundaries.

Cluster covering 2 related competencies including: Psilocybin psychoeducation, Psychedelic psychoeducation and expectation management.

Therapists should support evaluation, emotional processing, and integration after the acute experience. This includes helping patients reflect without over-directing or interrupting the process.

Adapt language and interpersonal style to the patient’s preferences to promote dignity and comfort. The therapist should also respect the patient’s autonomy within safety limits.

The therapist must create an atmosphere of confidence and mutual understanding before ketamine administration. This relationship is treated as a key therapeutic factor in the protocol.

Therapists should communicate in language and nonverbal style the participant can readily follow, avoiding overly theoretical or confusing discourse.

Cluster covering 2 related competencies including: Session facilitation and therapeutic holding, Session facilitation and support during intense experiences.

The protocol implies that facilitators should have specific psychiatric, psychotherapeutic, or psycholytic therapy training relevant to altered-state treatment. Specialized experience supports safe and effective delivery of LSD-assisted psychotherapy.

Cluster covering 2 related competencies including: Integration of psychedelic experience with behavior change, Facilitate integration of experience into behavioral change.

Facilitators are responsible for ensuring that participants have provided informed consent before receiving MDMA-assisted therapy. This reflects an ethical and regulatory duty central to work with investigational treatments.

Therapists must protect voluntariness when potential participants are also their patients. Independent evaluation should be used to reduce pressure or perceived coercion in recruitment and consent.

Therapists/facilitators need judgment about dosing and setting so experiences remain tolerable and therapeutically useful. The paper repeatedly notes that when dose and setting are appropriate, emerging material remains within the patient’s capacity to cope.

Study clinicians are responsible for administering study drug, ensuring correct dose assignment, and supervising safe oral ingestion during blinded sessions. This includes verifying visit-specific randomization information and ensuring dosing is delivered under the blinded workflow.

Therapists must meet licensure requirements and work within supervision structures appropriate to their training and role. Unlicensed or PAP-inexperienced staff require direct supervision.

Coordinate effectively with the study clinician, medical monitor, rater team, and MRI staff. Facilitation is embedded in a broader clinical-research workflow requiring timely communication.

Understands and applies the protocol-defined criteria for treatment-resistant major depressive disorder, including diagnostic confirmation, episode severity, and prior treatment failure requirements. Must verify both current and historical antidepressant nonresponse and ensure the participant remains eligible at baseline.

Know the sequence, timing, and purpose of screening, preparation, dosing, scanning, follow-up, and unblinding visits. The therapist/facilitator must be able to work within the full protocol structure.

Teaches clinicians to recognise their role boundaries, align services with training, licensure, supervision, and organisational policy, and refer or escalate when participant needs fall outside their scope of competence.

The course explicitly mentions the role of music and therapist variables in treatment. Learners are expected to understand how these elements influence the PAP experience and therapeutic outcome.

The page points to checklists and a guide to basic medical emergencies, indicating that learners should be able to monitor safety and recognize urgent issues. The overall training context also stresses keeping both client and practitioner safe.

The intervention involved two separate psilocybin dosing sessions 3 weeks apart under a randomized controlled protocol, implying the need for facilitators to reliably support treatment according to a fixed schedule and study procedures.

Document participant experiences and relevant observations to support continuity, recall, and study integrity. Notes may also serve as a participant memory aid after dosing sessions.

Competent facilitation requires practical knowledge of dosage ranges, initial dosing, boosters, formulation handling, and administration errors. The handbook stresses both clinical judgment and meticulous procedural care.

Help the patient identify personally meaningful, positive intentions to guide the session and future change. Intentions should be active, concrete, and framed toward desired gains rather than avoidance.

Therapists must listen with nonjudgmental, emotionally attuned presence and convey validation, reassurance, and curiosity. They should be able to stay relaxed yet engaged, including noticing nonverbal cues and responding without prying.

After each MDMA session, therapists must assess whether continuing treatment is safe and clinically appropriate. The participant’s choice is respected unless safety concerns warrant exclusion.

Therapists/facilitators must support ethically valid informed consent by ensuring participants understand the intervention, expectations, risks, and logistics. They also provide anticipatory guidance before ketamine sessions and discharge information after dosing.

Combined ketamine infusion and PE treatment requires coordination between psychotherapy providers and medical/anesthesia or medication administration staff. Effective collaboration supports timing, safety oversight, and protocol fidelity.

Understands the therapeutic role of ayahuasca as a psychoactive plant brew used ritually in traditional Amazonian medicine. Knowledge of the cultural and medicinal context is necessary to support safe and appropriate facilitation.

Respond to agitation or attempts to leave the room in a way that preserves safety for the patient and others. The therapist should use containment, redirection, and escalation protocols when needed.

The study emphasizes the absence of acute or chronic adverse effects persisting beyond 1 day and no treatment-related serious adverse events, indicating the need for active monitoring during and after treatment. Facilitators must be able to observe, document, and respond to adverse reactions.

The facilitator must ensure non-responders are transitioned safely back to clinical care. Continuity of care is explicitly required to support ongoing psychiatric treatment.

Understands the drug’s rapid absorption profile and lack of accumulation with repeated dosing. Uses this knowledge to anticipate timing of effects and safety observations.

Teaches clear communication of behavioral requirements before dosing sessions so conditions are standardized and preventable risks are reduced. Staff confirm that participants understand and follow pre-session instructions.

Understand the major medical risks associated with ibogaine administration, especially cardiac and neurologic toxicity, before proceeding with treatment. This includes recognizing that ibogaine has been linked to torsades de pointes, QTc prolongation, bradycardia, and ataxia.

Follows the study's operational rules for dose timing, progression, and stopping conditions. Reliable execution is necessary for both safety and interpretability of results.

Understand and apply a therapeutic framework centered on psychological flexibility. The intervention was explicitly described as time-limited and relational, with this focus guiding therapist work.

Monitors for potential adverse effects associated with ibogaine administration and the detoxification period, even though the abstract primarily reports outcomes rather than specific events.

At least one therapist must be able to teach stress inoculation methods, especially diaphragmatic breathing, and apply breath-based interventions during sessions. Breath is used both for relaxation and for staying present with difficult experience.

Facilitators must competently administer and interpret clinician-rated ADHD and global severity measures. Accurate scoring is essential because these scales determine eligibility and outcomes.

Therapists must be able to help participants confront, tolerate, and work through intense experiences rather than prematurely suppress them. The method emphasizes support, reassurance, emotional processing, and integration of meaningful material.

Therapists must have a thorough understanding of MDMA’s subjective, relational, and physiological effects, including the non-linear way these may support healing. This knowledge is necessary for preparation, in-session decisions, and normalization of participant experiences.

Students learn to use language and questions that deepen a client’s inner experience and support healing. This is a practical communication competency for facilitation and integration work.

Teaches psychoactive substance pharmacology, expected drug effects, contraindications, and relevant drug-interaction risks. The competency supports safer screening, medication review, participant education, and clinical decision-making.

Therapists should understand the participant’s support network and appropriately involve support persons when relevant and desired.

Uses assessment findings to individualize therapy and medication-session preparation. Adapts the approach based on participant response, goals, and clinical presentation.

Teaches the use of independent or blinded assessors to reduce expectancy and observer bias, preserve separation between therapeutic and rating roles, manage unblinding risks, and protect outcome validity in open-label or partially blinded designs.

Monitor for ibogaine-associated cardiac toxicity, especially QTc prolongation and risk of torsades de pointes. This includes baseline exclusion screening, frequent ECG surveillance, and escalation when QTc becomes markedly prolonged.

Ability to monitor for short-term cognitive impairment following psychedelic administration. The study included tests designed to detect decrements in attention and processing speed.

Therapists function within a medically supervised ketamine model and must coordinate closely with clinicians responsible for dosing oversight and safety clearance. This includes understanding role boundaries and supporting monitoring workflows.

Have formal training in MDMA-assisted therapy before treating participants. The protocol notes that study therapists were trained in an MDMA-assisted therapy program from prior clinical-trial experience.

Can safely administer vaporized GH001 using standardized equipment and procedure. Accurate delivery and participant instruction are essential to reliable dosing.

Use brief mindfulness practices and grounding strategies to stabilize attention and reduce distress before and during the session. These techniques help the patient reconnect to present-moment awareness and bodily sensation.

Work within an approved research framework that has institutional review board authorization. Ethical practice requires adherence to the approved study protocol and oversight requirements.

Facilitators need to understand the full treatment sequence and how each phase contributes to safety and treatment delivery. The intervention depends on correct sequencing and timing.

Safety monitoring in this context includes tracking not only adverse psychiatric states but also broader psychological, emotional, existential, and spiritual outcomes. Clinicians should watch for changes across multiple domains that may affect patient functioning and care needs.

Teaches screening for MRI contraindications and coordination of imaging clearance before scan procedures. The competency prevents exposure of ineligible participants to magnetic-resonance risks and supports safe imaging-session logistics.

The facilitator must minimize bias in how assessments are administered and in how participant responses are handled. This is important because the trial is open-label and relies heavily on patient-reported outcomes.

When overnight stays are required, facilitators and attendants must maintain safe observation and supportive presence without acting as outside therapists. They need to monitor comfort, safety, and emergency access overnight.

Evaluates opioid withdrawal symptoms and tracks changes over time in participants discontinuing methadone OST. Uses standardized withdrawal ratings to assess potential treatment effects and safety.

Ability to observe and respond to participants during MDMA medicine sessions, including both psychological experience and physiological change. The protocol indicates an interest in psychological and physiological processes of change during treatment.

Ability to manage the study schedule, windows, and follow-up procedures accurately. This supports treatment delivery and valid outcome collection.

Therapists must understand MDMA’s expected subjective, interpersonal, and physiological effects and prepare participants accordingly. This knowledge supports normalization, reassurance, and effective use of the medicine within therapy.

Facilitators need practical skills in preparing participants emotionally for ketamine administration and reducing distress. The protocol highlights relaxation, breathing, and grounding strategies to reduce anxiety or discomfort associated with the drug experience.

Deliver ongoing relapse prevention psychotherapy after dosing through the post-dose follow-up period. The approach is used to support alcohol recovery and translate treatment effects into behavior change.

Ability to administer standardized clinical ratings consistently and under supervision. Reliable measurement is essential for efficacy and safety endpoints.

Therapists must pace the day appropriately, from early dosing to flexible termination, avoiding premature ending that could destabilize the subject. The handbook presents timing as an active facilitative skill rather than a logistical detail.

Because the protocol involved specific LSD doses, active placebo control, and session spacing, facilitators need applied skill in implementing dosing-session procedures safely and consistently. This includes maintaining therapeutic support while adhering to protocol constraints.

Therapists should identify or teach in-session coping tools and collaboratively plan how anxiety states will be recognized and supported.

Help patients engage in emotionally intense trauma-focused treatment and reduce dropout risk. The therapist should recognize comorbid depression or anxiety that may interfere with adherence and response.

Teaches the requirement for site personnel to be trained and certified on protocol-specific assessments, psychiatric instruments, rating scales, and study procedures before performing them in the trial.

Therapists must be specifically trained in psilocybin-assisted psychotherapy and in the study’s manualized procedures. Competence includes familiarity with the therapeutic model and difficult-state management guidance.

Therapists need a solid professional background in psychotherapy, especially PTSD treatment. Prior experience with established trauma therapies and related approaches is considered important preparation for this work.

Apply Acceptance and Commitment Therapy as the primary psychotherapeutic framework, while using other modalities as clinically indicated. The protocol also references CBT, psychodynamic approaches, and Internal Family Systems.

Therapists must help participants identify, recover, and translate values into concrete behavior change. The manual treats values work as central to depression recovery and integration.

Cluster covering 5 related competencies including: Harm-reduction orientation, Harm reduction and risk awareness, Harm reduction for client support.

Cluster covering 2 related competencies including: Trauma-informed care, Trauma-informed psychedelic care.

Teaches practitioners to read and understand clinical protocols, treatment manuals, and evidence-based psychedelic care procedures. The focus is knowing how protocol requirements shape preparation, dosing, integration, documentation, and safety responsibilities.

Teaches practitioners to identify and apply relevant legal, regulatory, ethical, and institutional requirements, including documentation, consent, reporting, controlled-substance, and jurisdiction-specific obligations.

Cluster covering 2 related competencies including: Facilitation of psychedelic journeys, Psychotherapeutic facilitation methods.

Cluster covering 2 related competencies including: Dosing-day facilitation, Dosing-session facilitation.

Therapists must understand participant distress through an Acceptance and Commitment Therapy lens and use that formulation throughout preparation, dosing, and integration. They identify psychological inflexibility processes and track movement toward or away from psychological flexibility.

Track the participant’s subjective drug intensity during the active phase of the session. This includes recognizing when the participant cannot respond and how to document maximum intensity.

The therapist must exercise clinical judgment about who may benefit, who may have difficulty surrendering defenses, and where evidence is limited. The handbook emphasizes uncertainty, need for research, and cautious selection based on insecurity, rigidity, suspicion, diagnosis, and treatment goals.

Track onset, duration, and phases of ibogaine effects as part of clinical monitoring. The manual describes multiple stages of effect and expects the provider to observe them carefully.

Facilitators need basic knowledge of ayahuasca composition, dosing, and interaction risks to support safe administration. The protocol emphasizes dose calculation, substance composition, and monitoring for contraindications.

Collect and interpret baseline behavioral, psychiatric, and medical history relevant to psilocybin research. This information is used to determine eligibility and contextualize outcomes.

Work within protocol-defined limits of therapist support. The trial excluded participants whose conditions could jeopardize rapport given those limits, underscoring the need for clear boundaries.

Facilitators require skill in establishing ceremonial and intentional framing around ketamine sessions to support therapeutic depth and coherence. This includes preparing participants for the significance and structure of the experience within the group model.

Therapists must skillfully time check-ins and interventions to sustain process without unnecessary intrusion. They monitor silence, talking, avoidance, and signs of internal engagement to decide when to inquire, redirect, or simply witness.

Facilitators should create a safe interpersonal environment conducive to disclosure and processing. The setting is intentionally designed to support openness, comfort, and trust.

Tracks dose-dependent changes without assuming full psychedelic effects. This includes recognizing that low-dose exposure may modulate brain activity while remaining sub-psychedelic.

Understand the role of serotonergic mechanisms and the implications of receptor antagonism for acute psychedelic effects. Use this knowledge to interpret responses and co-administration effects.

Ensure that administration occurs within an ethically supervised research or clinical framework with informed oversight and careful risk-benefit consideration. Hallucinogenic agents require especially cautious use in vulnerable psychiatric populations.

Therapists/facilitators must ensure participants are properly informed using approved consent materials before participation in MDMA-assisted psychotherapy research.

Therapists must work thoughtfully with the patient's social support system to enhance safety and continuity of care. This includes selective disclosure, education, involvement in sessions when appropriate, and crisis planning.

Safe delivery requires coordination among therapists, physicians, nurses, blinded assessors, outside therapists, and emergency services.

The therapist/facilitator should know the expected onset, peak, and persistence of effects to guide monitoring and interpretation. The source reports acute effects with follow-up improvements lasting days.

Therapists must provide continuity, availability, and clear support structures after MDMA sessions to reduce anxiety and manage emerging difficulties. This safety net extends beyond the dosing day.

Therapists/facilitators must fulfill professional legal duties and escalate safety or reporting concerns promptly.

Therapists in this setting must recognize abnormal cardiovascular responses and follow protocolized responses for hypertensive crisis, angina, myocardial infarction, or stroke.

Recognizes medical factors that may increase risk during inhaled 5-MeO-DMT administration. Medical clearance is required before dosing.

Coordinate the conversion from opioid maintenance treatment to morphine-sulphate prior to ibogaine dosing, reflecting the treatment sequence described in the study. This requires careful timing and clinical oversight.

Performs targeted nasal examinations and assesses local tolerability of esketamine nasal spray. Identifies findings that could affect drug delivery, safety, or continuation.

Recognize and respond to gastrointestinal adverse effects that may occur frequently with higher doses. Manage emesis to reduce aspiration risk, dehydration, and treatment disruption.

A study physician with psychiatric and cardiovascular emergency expertise must be available during dosing. This reflects a requirement for advanced emergency readiness and clinical judgment.

Treat consent as a continuing process rather than a one-time event. Patients must understand the treatment and retain the ability to revoke consent, with special procedures during the medication session for safety.

Knowledge of the trial’s primary, secondary, and exploratory endpoints and the instruments used to assess them. This enables accurate administration and interpretation of study procedures.

Facilitators are expected to monitor for signs of misuse, diversion, dependence, or other abuse-related phenomena even though the medication is administered only on-site. They must also recognize protocol violations or dropout patterns that may signal abuse liability concerns.

Monitors patients closely during treatment because serious adverse outcomes may occur. Safety monitoring is essential given that one participant died during treatment in the study.

Ability to assess whether the target acute psychedelic experience has occurred using the study-defined scale and threshold. This was used to guide individualized dosing.

Understand ibogaine, noribogaine, and noribogaine glucuronide disposition and how exposure relates to clinical effects. This knowledge supports safe interpretation of observed toxicity and response.

A major therapist competency is preparing patients extensively for the ketamine session, including the nature of the special state of consciousness and possible ego dissolution or separation from the body. Preparation is both educational and psychotherapeutic.

Identify and document possible post-dose reactivation or flashback-like experiences. The therapist must capture timing, context, emotional valence, and functional impact of these events.

Facilitators need knowledge of conditions and medications that may make 5-MeO-DMT unsafe or inappropriate. They should identify possible interactions and discuss them clearly before participation.

Facilitators should understand that treatment aims include symptom reduction and improved functioning. Support work should attend to both emotional processing and real-world disability.

Given the risk of high attrition, facilitators need strong engagement and follow-up skills. The protocol explicitly notes the importance of respecting time commitments, tracking procedures, and strong interpersonal skills of study personnel.

Collaborates with patients, medical practitioners, and referring providers to support individualized care. Helps patients consider alternatives and coordinate ongoing treatment needs.

Ability to facilitate long-duration psychotherapy sessions in a controlled research setting. The study used two 8-hour psychotherapy sessions, requiring sustained therapeutic presence and session management.

Because cognitive performance during treatment is a named secondary outcome, clinicians involved in care should be able to monitor and document cognitive functioning relevant to treatment participation. This supports safety oversight and interpretation of treatment effects.

The therapist/facilitator or designated rater must administer and interpret multiple structured clinical scales reliably. Training and separation of roles are required to preserve rating quality and blinding.

Understand the expected acute physiological effects of BPL-003 and monitor for clinically meaningful changes. The facilitator should recognize that transient blood pressure and heart rate increases may occur.

Measure opioid withdrawal severity using standardized instruments and interpret symptom severity over time. Facilitators must be able to collect both objective observation and patient-reported data.

Psilocybin sessions are conducted with two trained therapists, and therapists-in-training may support sessions under supervision. Effective dyad work and supervised learning are central to the model.

LSD-assisted psychotherapy in this study is explicitly framed as medically supervised. Therapists/facilitators need to practice within a setting capable of medical oversight and management of prolonged altered states.

Because this is a randomized controlled trial comparing ketamine with active placebo, clinicians must respect trial procedures that protect scientific integrity and participant welfare. This includes adherence to allocation procedures and avoiding actions that could compromise blinding.

Cluster covering 2 related competencies including: Preparation and therapeutic alliance, Preparation and therapeutic alliance building.

Cluster covering 2 related competencies including: Psychedelic integration support, Psychedelic knowledge integration.

Cluster covering 2 related competencies including: Trauma-informed practice, Trauma-informed clinical practice.

Recognize and classify events relevant to abuse liability, intoxication, misuse, dissociation, and overdose. The protocol specifies preferred terms that should be considered as AESIs when appropriate.

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.

Ensure required abstinence conditions are met before dosing and make clinical judgments about rescheduling or exclusion when they are not. This protects safety and protocol integrity.

Administer study assessments in the correct order and in the correct format. The protocol depends on reliable, standardized administration by trained site personnel and central raters.

Before administration, facilitators should assess readiness and factors that could increase the chance of a difficult session. The source highlights that preoccupation, rigidity, low trust, and poor support can worsen experiences.

Understand how therapeutic alliance is measured and interpreted in psychedelic-assisted therapy research. The study used the WAI-SR with goal, task, and bond subscales.

Assess for cerebellar adverse effects such as ataxia during and after ibogaine administration. The source indicates ataxia is likely driven by ibogaine exposure and should be tracked systematically.

Trained staff must administer and/or supervise a battery of behavioral tasks and self-report instruments consistently across baseline and drug sessions. Some measures are verbally administered by clinicians or coordinators and require standardized delivery.

Navigate the combination of psychedelic support and AUD therapy while preserving clear therapeutic boundaries. The facilitator must deliver supportive care without role confusion or undue influence.

Performs repeated blood pressure screening and interprets values against protocol thresholds before allowing dosing. This includes recognizing measurement artifact and repeating readings when needed.

Exclude or defer patients whose medical risk is too high, especially those with cardiovascular disease or other major contraindications. This is central to safer administration according to the source.

Uses observed patient response to help optimize how ketamine-assisted psychotherapy is administered. Informs future clinical decisions about approach and dosing strategy.

At least one therapist in the dyad must be a clinician with capability to assess and manage medical or psychiatric adverse events during the dosing session. This reflects a required competency boundary between general support and clinical responsibility.

Ketamine-assisted treatment in this protocol is multidisciplinary, so facilitators must work closely with study doctors and nurses. This includes coordinating preparation, understanding monitoring responsibilities, and escalating concerns appropriately.

Facilitators and treating clinicians must understand and operationalize the study-specific timing between infusions and exposure sessions. This includes aligning infusion administration 24 hours before PE sessions during the first 3 weeks.

Implement infection-prevention procedures during in-person study and dosing visits. Facilitators must screen participants, use PPE, maintain distancing when feasible, and adapt procedures based on test results or symptoms.

Use pharmacogenetic information to anticipate altered ibogaine metabolism and exposure. The study identifies CYP2D6 activity as a major determinant of ibogaine clearance.

The therapist/facilitator must record participant-reported effects and clinically relevant observations accurately. Documentation supports both safety monitoring and outcome interpretation.

Plan ibogaine dosing based on patient status, formulation, prior opioid exposure, and therapeutic goals. The manual presents both single-dose and multi-dose approaches and stresses patient-specific judgment.

Assess for physiologic factors that may increase ibogaine-related harm, especially electrolyte abnormalities. The source identifies electrolyte screening as part of safer administration.

Understand the common and serious adverse effects, interaction risks, and monitoring needs of escitalopram. This includes cardiac, psychiatric, sexual, and withdrawal-related concerns.

Prevent dehydration during and after ibogaine treatment. The manual stresses that patients may not feel like drinking and that dehydration can become dangerous, especially if vomiting occurs.

Knows the use of ibogaine as a detoxification agent in medical and nonmedical settings and understands that its mechanism of action is novel and not fully established.

Understand the unique cardiovascular hazards associated with ibogaine and the need for intensive cardiac oversight. The facilitator should know that cardiac risk is a central safety issue rather than a minor side effect.

During ketamine administration, the therapist provides continuous emotional support while the patient reclines with eyeshades and music. This support helps the patient tolerate and make use of the psychedelic experience.

Use ibogaine only after a careful discussion of uncertain efficacy, limited research, and known risks. Ethical practice requires transparent communication about the experimental nature of treatment and the absence of robust clinical standards.

Exercises heightened ethical responsibility when working with people with opioid dependence undergoing medication changes. Ensures participation remains voluntary, monitored, and clinically appropriate.

Understand that changes in cerebral blood flow were observed after ayahuasca intake in regions implicated in mood and emotion regulation. Facilitators should be able to contextualize these findings without overinterpreting them clinically.

Collect biological samples and interpret their role in safety and exploratory analyses. Facilitators need procedural competence in sample handling and visit timing.

Ability to administer LSD in a psychotherapy setting using the regimen described in the source. The therapist/facilitator must understand session-based dosing and treatment course structure.

Plans and maintains support for sessions that may last many hours. Duration of effects can be substantial and requires sustained facilitator availability and structured observation.

5-MeO-DMT produces a very short but intense experience, which changes facilitation demands. Facilitators must be prepared for rapid transitions into and out of the altered state.

Therapists must understand clinically significant drug interactions with ibogaine, including QT-prolonging, serotonergic, centrally acting, and CYP2D6-related medications. This knowledge informs screening, tapering, and dosing decisions.

Train and support participants in use of the study app for dosing, questionnaires, journaling, and reminders. This includes technology-enabled adherence monitoring.

Use video-based direct observation methods to verify medication intake and prevent dose stacking. This is a core adherence-monitoring function in the protocol.

Because study drug delivery uses a vaporization device, staff must be able to recognize, document, and escalate device deficiencies. Device issues may have safety implications even when no patient harm occurs.

Understand the intranasal administration procedure and related local adverse effects. The facilitator must support safe delivery and monitor nasal reactions.

Sequences study procedures correctly to reduce bias and protect participant safety. Particularly prioritizes PROs, clinician ratings, and dosing-day procedures in the required order.

Identify study-drug overdose and respond according to protocol with urgent sponsor notification and clinical monitoring. The protocol defines overdose as more than the assigned dose for that subject.

Prepare participants to correctly use nicotine replacement therapy when assigned to the control arm. Facilitators must provide education, dosing instructions, and side-effect guidance.

Supports structured administration and observation within a clinical trial or supervised research setting. Uses protocol-based timing, assessments, and follow-up consistent with phase I human studies.

Understands core pharmacokinetic concepts needed to interpret study findings and guide safety observation. Recognizes dose-linear exposure changes and elimination characteristics relevant to monitoring windows.

The therapist/facilitator must ensure medical suitability before ayahuasca administration by checking for conditions that increase risk. Screening should include physical exam, laboratory testing, and pregnancy assessment when indicated.

Therapists must prepare participants psychologically and practically for ketamine dosing through rapport-building, psychoeducation, expectation-setting, and intention development. Preparation is emphasized because of trauma burden, psychiatric comorbidity, and instability in the target population.

Verify the formulation and potency of the ibogaine product before administration. The manual warns that confusion between HCl, extract, and root bark can cause underdosing or fatal overdosing.

All patients in the trial received psychological support in conjunction with medication administration, indicating that facilitators must be able to deliver structured supportive care as part of the treatment model.

Understands the dose-dependent pharmacokinetics and expected duration of oral mescaline effects. Can anticipate onset, peak, and offset based on the measured human PK/PD profile.

Initiates, uptitrates, and monitors quetiapine XR augmentation in the comparator arm according to age-specific schedules and tolerability. Recognizes the therapeutic minimum and discontinuation triggers.

Understands that mescaline is a classic serotonergic psychedelic with substantial acute psychoactive effects. Uses this knowledge to prepare for altered perception and prolonged subjective responses.

Understand the rationale and risks of home-based psychedelic microdosing in a naturalistic environment. Facilitators need awareness of adherence, stacking, and behavioral risk considerations.

The facilitator should understand the administration context for the intervention. The source highlights inhalation as the studied route and its rapid onset.

Facilitators need working knowledge of administration routes because onset, duration, intensity, and tolerability vary substantially. This informs preparation, monitoring, and participant education.

Clinicians must ensure participants meet day-of-session safety requirements before psilocybin is administered. This includes verifying toxicology, pregnancy, alcohol abstinence, and adherence to protocol restrictions.

Facilitators must be able to deliver psilocybin only as an adjunct within a structured 15-week smoking cessation protocol rather than as a standalone intervention. This requires integrating psychedelic sessions with established tobacco cessation treatment methods.

Supports rigorous conduct of randomized controlled safety studies by maintaining protocol adherence and minimizing bias. Protects the validity of safety, tolerability, and exploratory efficacy assessments.

Confirm ongoing eligibility throughout the study and recognize conditions that require withdrawal or reassessment. Eligibility is not static and must be checked before key sessions.

Administers repeated sublingual microdoses of 5-MeO-DMT in a controlled clinical trial setting. Must follow the assigned dose schedule and maintain blinding across active and placebo conditions.

Ability to support supervised at-home ketamine use when clinically appropriate. This implies monitoring and structure even outside the office setting.

Therapists must create and maintain a calm, supportive setting during MDMA administration. The session environment is intended to maximize comfort and facilitate therapeutic work while minimizing risk.

Support clear agreement on what the participant and facilitator are doing together in the therapy process. In this study, task alliance showed particularly robust associations with outcomes.

Support accurate administration of the investigational product and active placebo in a double-dummy design. The facilitator must understand the dosing workflow and dosing-day requirements.

The intervention involved two dosing sessions with either low-dose or high-dose LSD, implying facilitators need knowledge of session-based LSD administration frameworks. This includes understanding that psychotherapy support is paired with specified dosing regimens.

Facilitators require knowledge of the therapeutic context, including that psilocybin is being investigated as a rapid-acting treatment for major depressive disorder. This includes understanding the expected timeframe of symptom assessment and response.

The facilitator must understand why bipolar II participants require enhanced monitoring and conservative dosing. The protocol is built around the risk of mood destabilization in this population.

Recognize that current evidence does not establish the lowest effective or safest exposure for ibogaine. Facilitators must understand the uncertainty surrounding efficacy at reduced doses.

Understand the domains assessed in the Storyline psychiatric and neurological interviews and use this knowledge to support accurate administration and interpretation of study tasks. Domains include cognition, mood, homeostasis, social support, and psychosis/suicidality screening.

Knowledge that KAP may be delivered without intravenous access and that non-IV office-based use is part of the described practice model. This reflects a shift from IV-only psychiatric use to broader administration approaches.

Help participants direct attention to their own present-moment internal experience and explore it from multiple perspectives. This is practiced in preparation and used to support participants if challenging material emerges during dosing.

Teaches applied competence through role play, case discussion, peer consultation, seminars, mentorship, and learning-community structures. The emphasis is translating theory into practice, receiving feedback, and developing reflective clinical judgment with peers.

Cluster covering 4 related competencies including: Ethical practice, Ethics in psychedelic care, Ethics and ethical practice.

Teaches the neurobiological basis of psychedelic and non-ordinary states, including default mode, salience, fear, and related brain-network models. The competency links altered-state phenomenology with therapeutic mechanisms and clinical implications.

Cluster covering 2 related competencies including: Dosing-session framework, Dosing-session framework use.

Cluster covering 2 related competencies including: Psilocybin prescribing fundamentals, Prescribing fundamentals for psychedelic treatment.

The course also teaches a more active guiding style, especially through Ralph Metzner’s approach, where guides may introduce focused inquiries, somatic practices, or other interventions. Learners are shown how interventions can shape the trajectory of a session when used skillfully.

The program includes supervised apprenticeship hours with pre-approved mentors. Learners are expected to observe, assist, and translate training into supervised practice.

The page highlights best-in-class clinical training for drug trials and AI-supported evaluation. Learners are expected to refine skills quickly and receive targeted feedback in training or evaluation contexts.

The program emphasizes that it prepares people for therapeutic and facilitative roles within a collaborative care framework, not independent medical practice. Learners are expected to understand role boundaries, especially around prescribing and administration.

The course teaches learners to distinguish between classic psychedelics and emerging therapies within therapeutic applications. This is a foundational comparative literacy competency rather than a protocol-specific skill.

Contemplative practice is included as a core domain, suggesting learners are exposed to practices that support presence, reflection, and self-regulation in facilitation work. This likely supports both practitioner preparation and client-facing care.

The course explicitly teaches techniques for working with patients in altered states, including grounding, breathwork, and mindfulness. These are presented as tools for supporting expanded and ordinary states of consciousness.

The overall program emphasizes experiential, relational, and community-grounded learning, including retreat and practicum components. Learners are expected to develop a grounded facilitation presence in addition to theory.

Learners are taught to design custom protocols for both microdosing and macrodosing based on client goals. The page also references microdosing formulas and practical application of timing and dosage nuances.

Learners are expected to develop the ability to witness clients and processes calmly, without overreacting or trying to control the experience. The course explicitly frames this as foundational to practitioner development.

The course explicitly states that facilitators are guided in safety, ethics, and responsibility. Learners are expected to recognize and manage the unique risks of working with altered states.

The course teaches the overall PAP workflow from screening through follow-up. Learners are expected to understand and explain each phase of treatment in a structured way.

A defining feature of the training is hands-on experiential practice in both non-substance and substance-based modalities under supervision. Learners practice patient and therapist roles, facilitating and undergoing sessions in a structured learning context.

Students complete 50 supervised practicum hours and receive expert feedback while working with real clients. This is intended to translate theory into competent applied practice.

The program states it prepares facilitators to address the needs of clients, patients, or community members from diverse faith traditions and communities of origin. Learners are expected to adapt facilitation to varied settings and worldviews.

The Colorado practicum site explicitly teaches relational competence, including tracking nervous systems, power, and consent dynamics moment by moment. This is presented as a core facilitation capability.

The course teaches students to guide both in-person and online sessions, including the technical skills needed for virtual facilitation. It explicitly notes that online training includes learning tech skills to become a confident virtual guide.

The program states that the virtual training has been streamlined so students feel safe and supported no matter what arises. This signals competency in maintaining safety in online psychedelic support contexts.

Catch-all cluster covering 189 general competencies for psychedelic-assisted clinical practice that did not group into a more specific category — including miscellaneous facilitation, monitoring, ethics, safety, regulatory awareness, group support, and program-specific skills not captured by dedicated clusters elsewhere.