PSYCHEDELIC-ASSISTED PSYCHOTHERAPY IN DETAIL

 

Screening and assessment 

 

Patients are screened by Dr Bench to assess their overall mental health, suitability, and safety of MDMA assisted psychotherapy. 

 

Patients are asked to bring a GP referral detailing full medical history with results of relevant assessments to their assessment:

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• Physical screening

• Pathology:

  1. Liver and renal function

  2. pregnancy test

  3. full blood count

  4. metabolic profile

  5. thyroid hormones 

  6. blood or urine drug screen

  7. ECG

 

Psychiatrist assessment:

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Psychiatric assessment assessing diagnosis and whether MDMA PAP would be a safe and suitable treatment option:

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• duration of the current episode

• years from first diagnosis

• number of previous episodes

• type and dose of current and previous treatment

• family history of mental illness

• eligibility, and exclusion criteria. 

 

Dr Bench makes the final determination of the person’s eligibility. The person will then be informed regarding their eligibility as well as their treating doctors/psychiatrist of the screening outcome and treatment recommendation. If additional information needs to be collected for a decision to be made, a further appointment may be required.

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A case conference call between psychiatrist and treating GP occurs to confirm suitability for PAP and any concerns before proceeding. A summary of the assessment outcome is provided to referring general practitioner / professional with the patient’s consent. Prior to commencement of treatment, GP’s will receive notice that their patient intends to start a course of MDMA-assisted therapy and detailed information about the treatment and its side effects to assist with patient management.

Regarding any health concerns that the patient experiences during treatment, patients are advised to consult Dr Bench in the first instance. The prescriber will assess whether the health matter is related to the MDMA, or otherwise may direct the patient to their GP for matters unrelated to MDMA.

Informed consent is obtained for PAP when the person is assessed as eligible for PAP and prior to commencement of the program.

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Psychological assessment: 

• Semi-structured clinical interview:

  • Assess overall mental health and history

  • screening for psychosis

  • substance use

  • personality disorders

  • suicide risk assessment

 

• Review and explore results of questionnaires: 

  • AUDIT (Alcohol Use Disorders Identification Test)

  • DUDIT (Drug Use Disorders Identification Test)

  • DASS (Depression Anxiety Stress Scales 21)

  • PHQ9 (Patient Health Questionnaire 9)

  • IES-R (Impact of Event Scale Revised). 

 

If eligibility criteria are met and there is an absence of exclusion criteria, then the psychiatrist assessment will be scheduled to make the final decision as to the safety and suitability of PAP.

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Informed Consent 

 

Assessment of the person’s ability to consent will be accomplished by: 

 

• evaluating their capacity to recall program information

• evaluating their ability to summarise program information in their own words 

• evaluating their ability to reiterate the potential benefits and disadvantages of program participation 

• evaluating their capacity to discuss program information in a sensible, balanced, and logical fashion

• evaluating their understanding of and ability to adhere to requirements of the program. 

 

Informed consent for PAP treatment will be obtained on a HREC-approved consent form. Capacity to consent and participate will be monitored by the multidisciplinary clinical team throughout. If any of the patients appear to demonstrate a diminished capacity to consent and participate, except when undertaking the psychedelic drug sessions, they will be assessed by a psychologist or psychiatrist. As part of the consenting process and included on the HREC-approved consent form, patients will be asked to consent to video and audio recording throughout the dosing sessions. The purpose of the recording is for safety, quality assurance and training purposes. The recordings are securely stored and can only be accessed in accordance with relevant privacy laws and the clinic’s privacy policy. These videos will be held by the Prescriber for a period of 7 years consistent with storage of other patient medical records. The recording of dosing sessions is standard across clinical trials in psychedelic-assisted therapy and is recommended by MAPS MDMA-assisted therapy protocols to ensure safety, facilitate training and protocol adherence.

 

Eligibility Criteria:

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• Have a DSM-V diagnosis of PTSD 

• Ages 18-80

• Are willing to wean off and cease any medication contraindicated during the program

• Treatment-resistant symptoms (have failed at least two anti-depressants and one course of psychotherapy)

• Demonstrated capacity to give informed consent

• Willingness and capacity (as judged on assessment by treating clinicians) to engage in the therapeutic elements of the treatment protocol.

 

Exclusion Criteria:

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• Patients who are not able to give adequate informed consent.

• Current or previously diagnosed psychotic disorder, schizophrenia or bipolar disorder

• Immediate family member with a diagnosed psychotic disorder

• Significant history of mania

• Medically significant condition rendering unsuitability for the treatment (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure)

• History of serious suicide attempts in recent years requiring hospitalisation as judged by AP to impact on safety of participation.

• Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to MDMA, e.g., this may include Borderline Personality Disorder

• Positive pregnancy test at screening or during the program, women who are planning a pregnancy and/or women who are nursing / breastfeeding.

• Patients who do not agree to use an acceptable contraceptive method throughout their participation in the program.

• Recreational use in last 6 months of MDMA / psychedelic substances or a history of problematic MDMA / psychedelic use

• No email access / ability or no willingness to engage in follow up by electronic questionnaires

• Use of contraindicated medication (outlined further below) including MAOI (Monoamine oxidase inhibitors), SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI

• Use within 5 half-lives of any other serotonin-enhancing medication

 

List of contraindicated medications:

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(1) All antidepressants of all classes such as selective serotonin reuptake inhibitors and monoamine oxidase inhibitors.

(2) Typical and atypical antipsychotics.

(3) Mood stabilisers including lithium and anticonvulsants.

(4) Regular benzodiazepines or intermittent use within 72 hours of the medication session.

(5) All stimulants such as cocaine and amphetamines.

(6) Muscle relaxants and pain medications other than paracetamol, aspirin or ibuprofen.

(7) Over-the-counter dietary supplements such as 5-hydroxytryptophan and St John’s Wort.

 

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Preparation phase

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Once screened and assessed to be suitable for MDMA-assisted psychotherapy, the participant completes a minimum of three preparatory psychotherapy sessions with a therapist (psychologist, counsellor or psychiatrist) trained in psychedelic assisted therapy prior to the first dosing session. More preparation sessions may be provided if deemed clinically appropriate before proceeding to the first MDMA dosing session. The prescribing psychiatrist will review the patient during this process to ensure suitability for dosing. A support person will be invited to attend and ask questions about the program, they will be provided with a handout on how to support the participant after dosing including afterhours emergency procedure, phone numbers and clinical team contact details if needed.

 

In the event of an afterhours emergency, the patient and their support person will be advised to contact 000. A handout with emergency contact numbers will be provided to the patient and their carer support person, including information on how to contact Dr Bench’s clinic in the event of an emergency, including after-hours contact number. The patient and their carer support person will be advised to provide Dr Bench’s clinic details to any emergency provider along with advice regarding their participation in MDMA assisted therapy. 

 

Aims of the preparation sessions:

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• Alliance development and formulation: the primary aims will be the development of a therapeutic alliance, build trust and safety between the therapists and the participant. 

• Gain an understanding of participant’s trauma experiences, current impacts of trauma on their life, and treatment history to understand patterns of psychological inflexibility that are most prominent and ability to observe experience e.g., using mindfulness skills.   

• Formulate the person’s attachment history, and trauma history, assessment of target memories for the dosing.

• Clarify participant intentions for the medication session, anxieties and hopes for the experience. 

• Map persons internal system and any parts that have concerns around the MDMA experience I.e., trauma memories emerging and distress. Reassure any concerns and develop trusting alliance.

• Discuss ethical considerations and participant choices around use of touch, grounding techniques, and preferences such as music playlist, utilising eye mask, what can arise during a medication session, expectations and concerns and previous experience

• Psychoeducation around trauma, and the psychological and physiological effects of MDMA. Explain who will be present in dosing, and the integration process. Preparing social support and integration for after the dosing session. Support person invited into this process and will be informed of the nature of the treatment.

• Introduce concept of observing experience with curiosity and openness, and how MDMA facilitates this rather than avoidance which maintains trauma symptoms

• Grounding exercises and scripts for difficult experience, information on non-ordinary states of consciousness, based on the treatment manual. 

• Identify physical objects to bring to dosing that represent the client’s resources, in a similar way to the altar that is commonly used in the psychedelic space (Metzner, 1998). This is to have a tactile reminder of their team, peaceful place, and intention while potentially disoriented under the influence of psychedelics

• Collaboratively set intentions for the medicine session. 

• Discuss common experiences in MDMA session including transpersonal, spiritual aspects, feelings of safety, and approaching difficult and intense experiences with openness and curiosity.

• Collaborate on the use of various grounding exercises i.e., breathing techniques, consent for use of touch, use of music

• “Explain that use of touch in the dosing sessions is entirely optional, is never sexual in nature, and is intended to ground and steady a patient during evident distress. Therapists will discuss in depth during preparation to ascertain whether a patient consents to touch (patient-initiated, or therapist-initiated supportive touch) and what type of touch (such as hand holding or placing a hand resting on shoulder or forearm). The therapists will only provide supportive touch in the dosing session that has been consented to in preparation before taking the medicine, and only in service of supporting the patient during evident distress, and that the participant can withdraw consent to touch at any time during the dosing session without offending the therapists.”

• Practical guidance and safety instructions, including departure requirements with a nominated companion. 

 

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Dosing session(s):

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There will be one to three medication sessions. The medication sessions will be conducted in person at a minimum of three weeks apart. 

 

MDMA will be administered by two appropriately trained healthcare professionals with training on management of schedule 8 substances: 120mg of MDMA will be administered with a possible additional 60mg dose after 1 hour if recommended by Dr Bench. The optional supplemental half dose is to account for individual differences in sensitivity to MDMA. The participant will be guided towards a relaxed state by focusing on their breathing after MDMA administration. Within approximately 15 minutes of ingesting the MDMA, the participant will be encouraged to lie down, use eye shades and headphones, if they are comfortable doing so, and relax into the music selected for the session.

 

Dr Bench will be present on site during the MDMA dosing session, and the patient will be in a private room supervised at all times by two trained and experienced therapists throughout the dosing session (e.g. clinical psychologist, psychologist, psychiatrist, nurse or suitably qualified health professionals). The participant will have met with these therapists prior to the first dosing session. The participants vital signs will be monitored with appropriate medically trained staff (i.e., nurses or medical practitioners). The prescribing psychiatrist and an additional nurse trained in psychedelic assisted therapy available on site for support as needed.  

 

Dr Bench is available to prescribe rescue medications if required. At the conclusion of the dosing session, Dr Bench will review the patient to assess medical and psychological stability before they leave the site in the company of a support person. Each session will last up to eight hours and will be conducted with participants individually. Prior to the participant’s arrival, the room will be prepared such that it provides a safe, warm, private atmosphere with the provision for music, eye shades, gentle lighting and the ability for the participant to lie down with an appropriate blanket and pillow.

 

There will always be someone available to assist in the collection of vital signs as required. The medication will be prescribed and administered by Dr Bench.

 

Two therapists will be available for the entire dosing session, except for bathroom breaks with one therapist or support person with the participant at all times. Dr Bench will be onsite available for the duration of the dosing session and review each patient before and after the dosing, during the dosing as needed, and is available to prescribe rescue medications if required.

 

There will be a brief review of the expectations for the day.  For example, the patient is required to attend for between six and eight hours and will always be with at least one person at all times with medical staff on site throughout the duration of the session. Participants will be provided with an orientation to the space and location of a bathroom and informed of the availability of snacks and lunch. Therapists will review participant intentions for the medication session, and the techniques that the participant can use to deal with distress during a session (including asking for support, mindful awareness, use of music, touch, and focusing on the breath). Participants will have the opportunity to trial and make comfortable the headphones/music and eyeshades used for the session prior to taking the medication. Therapists check in again with the participant around consent for supportive physical contact prior to ingesting the medicine as well as assuring participant they can say no to these interventions without offending therapists.

 

Prior to commencement of the session, the participant’s blood pressure, pulse and temperature will be checked to make sure these are within the acceptable/normal range. If the participant is female and of childbearing potential, they will be asked to perform a urine pregnancy test.  A negative sample is required before medication administration.

 

 In the unlikely event that more serious medical complications occur which require intensive medical attention, an ambulance will be called via 000.

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Peak effects typically occur 70-90 minutes after drug administration and persist for 1-3 hours. The therapists will check-in with the patient after 1 hour if the patient has not talked since the administration of the medication. Approximately 1-2 hours into the dosing session, the patient is offered an additional 60 mg dose (if all vital signs are stable), as per the MAPS MDMA assisted therapy for PTSD protocol. This will occur under the supervision of Dr Bench. This check-in will be to remind the patient of the therapists’ presence and provides the therapists with a sense of the patient’s inner state. Based on this information, the therapists either encourage the patient to return to an inner focus or to share more about their inner experience. 

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If the patient demonstrates an interest in talking, the therapist will respond in a supportive manner and after a short time gently redirect the patient towards an inward-directed focus by encouraging them to focus on their attention to the body and/or the breath. More dialogue is expected towards the end of the session when the effects of the MDMA subside.

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Response to distress: 

 

The therapist/s will gently encourage the patient to ‘go towards’ or ‘lean into’ difficult emotional states rather than avoiding or trying to limit them. During difficult periods, one or both therapists may offer a supportive touch (if culturally and personally acceptable for the patient) by asking permission. Touch preferences will also be discussed and consented during the preparation phase. The therapists will encourage breathing exercises and remind the patient that they are in a safe place in order to help the patient stay with powerful emotional experiences rather than trying to suppress or avoid them.

 

Response to agitation: 

 

The therapist/s will encourage simple breathing exercises or grounding techniques. Often the invitation to focus inward and/or to bring awareness to the body and use the breath is enough to allow the patient to stay with a difficult experience and eventually move through it to new insights. However, if this is not successful, the therapists may offer some level of focused bodywork as an added catalyst to the process. 

If agitation escalates or does not appropriately settle, Dr Bench may prescribe rescue medication such as a benzodiazepine or antipsychotic medication. This will only be done as a last resort.

 

Response to paranoia: 

 

The therapist/s will reassure the patient that they are safe and remind them that they have taken a medication which is affecting their thinking. They may indicate that their thoughts will change with a certain number of hours and will resolve quickly at that time.

 

If paranoia escalates or does not appropriately settle, medical staff may prescribe rescue medication such as a benzodiazepine or antipsychotic medication. This will only be done as a last resort.

 

Response to requests for physical contact: 

 

The therapist/s will discuss with the patient prior to the session what they would consider acceptable and appropriate supportive touch and follow this guidance.  Consent for supportive touch will be attained in the preparation phase when the patient is in an ordinary state of consciousness.  A patient will make their own decision about consenting for touch in an ordinary state of consciousness (unmedicated)  – if they elect to consent to touch in an ordinary state of consciousness, they will be reminded they can withdraw such consent at any stage; if the patient does not consent to touch in an unmedicated state, they can not provide informed consent in a medicated state and as such can not in a medicated state then request supportive touch.  The issues and consequences of such will be explained to all patients prior to getting consent revolving around touch.

 

Discussion: 

 

In the last 30 to 60 minutes of the session the patient will be invited to talk about their experience, the emotions that were induced and to reflect on what they have been through. The role of the therapist will be to elicit the patient’s experience rather than to interpret these. This will involve the use of open-ended and explorative questions. One therapist will take notes that can be shared with the patient as a memory aid.

 

End of session:

 

The effects of MDMA will be expected to have markedly diminished by between six and seven hours. The therapist(s) and prescriber will assess whether the patient is ready to leave based on assessment of their mental state, vital signs, observation of coordination and steadiness of gait and whether the patient reports any lingering effects of the medication such as changes in vision, beliefs, thought processes or mood. The patient can only leave with a companion who is required to be with them for the rest of the day.

 

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Integration phase

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The patient will be offered three integration sessions that will take place within 24-48 hours after the first, second and third medication session. A minimum of nine integration sessions in total will take place throughout the minimum 12-week program. More integration sessions will be offered, as needed.

 

Dr Bench will review the patient after each dosing session and, if not part of the therapeutic dyad, at the final integration session prior to discharge. 

 

The purpose of the integration sessions is to support the participant in their ability to reflect on the medication sessions and to help them to reach insights that may have been developed. The primary activity of the therapist in these sessions is to ask open-ended questions to elicit insights that the participant may have come to. The therapist may identify elements of the participant’s trauma history and support adaptive information processing, translating insights into valued action in their life and recovery from PTSD. The integration sessions may also involve an exploration of values and how these may have evolved through the process of the treatment sessions. There may be some discussion of how the insights the participant has come to, and changes in their values, may be reflected in alterations they may make in specific day-to-day behaviours. 

 

If the patient has experienced worsening symptoms of PTSD by the time of the integration sessions, a full mental status examination and safety assessment will be conducted in conjunction with Dr Bench, and an appropriate follow-up plan will be developed. 

 

If it is identified during an integration session that a participant may benefit from additional sessions, this can be offered, though it is not required for all patients within the protocol.

 

The patient may withdraw at any stage.  However, if the patient has dosed with MDMA, the patient will be expected to complete at least a number of integration sessions in order to ensure safety of the patient.

 

 

Psychotherapy model

 

The psychotherapy approach is trauma informed and draws on the MAPS MDMA assisted therapy manual for PTSD. 

 

 

Known Adverse Effects and Mitigation:

 

In MDMA trials, adverse effects (AEs) have been rare and there have been no life threatening or serious adverse effects (SAEs).

 

Common side-effects:

• low appetite

• dry mouth

• difficulty concentrating

• sweating

• bruxism

• headache – including occurring up to 24 hours after dosing

• body temperature elevations above 1°C

• cardiovascular side-effects:

  • arrhythmias – rare

  • tachycardia - common

  • hypertension – common – mild and non-clinical elevation is usual

 

As a sympathomimetic, MDMA can cause increases in Blood Pressure (BP) and Heart Rate (HR). No patients required medical intervention in MAPS sponsored studies. Most individuals do not experience rises in BP and HR beyond that seen during moderate exercise. In a study of MDMA in 166 psychologically healthy individuals, transient severe hypertension (systolic blood pressure > 180 mmHg) was observed in 5% of patients on a 125mg dose of MDMA. The duration of these Adverse Events (AE) was not long enough to require medical intervention. Individuals with cardiovascular disease that is poorly controlled by medication are contraindicated in current studies, and as such will be excluded.

MDMA administered in controlled settings is not expected to pose hydration or temperature risks as patients are relaxed and are provided with fluids. However, in uncontrolled settings, particularly in hot environments accompanied by physical exertion (such as dance parties), MDMA may produce electrolyte imbalances which can be dangerous in vulnerable individuals. Electrolyte supplements will  be available on site. Patients will also be advised to consume a reasonable amount of water at the time of initiating the session (250-500ml), and their water intake will be monitored during the session.

 

HANDLING OF PATIENT WITHDRAWALS

 

If patients choose to withdraw from the treatment, they will be asked to notify a member of the clinical team to allow them to be informed of any health risks or special requirements linked to discharging and allow for handover to their usual treating team. Data collected up to the time they withdraw will form part of the outcome monitoring and quality/improvement of the program. 

 

If patients express a desire to withdraw consent from participation during a dosing session, after receiving their medication dose, they will be required to stay until the end of the session so that the clinical team and therapists can monitor their safety. This may also include collecting measurements of blood pressure and heart rate. Following the end of the session, if patients continue to wish to withdraw, no further data will be collected from them. However, they will be required to attend a discharge review with the treating psychiatrist to discuss the implication of ceasing treatments, and correspondence will be sent to the referring doctor and other nominated treating team shortly after the review. Where a patient declines a review, Dr Bench will discuss these implications and write correspondence to the referring doctor

 

Patients will be informed of the above processes prior to them providing informed consent.

 

WITHDRAWAL CRITERIA

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Patients will be discontinued from the treatment if they cannot continue the treatment safely based on any of the following criteria: 

 

(1) Experience a clinically significant worsening of PTSD or related symptoms judged by Dr Bench to warrant withdrawal

(2) Experience clinically significant suicidal ideation with imminent intent or attempted suicide; 

(3) Withdraw consent; or 

(4) Demonstrate inability to adequately engage in clinical procedures.

 

 

WOMEN OF CHILD-BEARING AGE

 

All sexually active patients of childbearing potential must agree to the use of an effective form of contraception in the time period from screening until one week after the final medication session. 

 

Examples of effective forms of contraception include:

• Established use of oral, injected or implanted hormonal methods of contraception  

• Placement of an intrauterine device (IUD) or intrauterine system (IUS)  

• Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)  

• True abstinence: When this is in line with your preferred and usual lifestyle   

 

Examples of non-acceptable methods of contraception include:

• Condoms alone or double barrier 

• Periodic abstinence (e.g., calendar based) 

• Withdrawal 

• Use of a spermicide 

 

 

ABILITY TO DRIVE AND USE MACHINES

 

Patients must agree to be accompanied home following dosing with MDMA on psychedelic drug treatment days and agree to not to operate a vehicle for at least 48 hours after initial drug administration for each therapy session. Patients will be asked to exercise caution and not drive if there is a possibility that MDMA may still be in their system and affecting their judgement and driving abilities. A letter will be provided to patients stating that they have received a medical treatment and the date after which it is safe for them to drive again, so that if they are stopped for a roadside drug test and the drug shows up in their system (which can occur for some days after the ingestion of the substance, long after the substance has stopped impairing their perception or decision making), they will be able to provide the letter.

 

 

AVAILABILITY OF RESCUE MEDICATION

 

Although there have been no reports of their use in well reported clinical trials with oral MDMA, medications will be available onsite in a doctor’s bag for the treatment of causal symptomatic hypertension, agitation, or severe psychotic symptoms should these arise. This will include lorazepam and/or diazepam, and risperidone or similar orally-disintegrating antipsychotic. Dr Bench will be on site / readily available during each MDMA session in order to prescribe these medications if required.