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Practitioner Information

An overview of the EMMAC Study with information and resources relevant to referring Health Practitioners.  

The EMMAC Study

Participants who have diagnosed advanced-stage cancer with associated depression and anxiety may be eligible for the EMMAC Study.


Referrals will be accepted from general practitioners, hospice, or oncology services.

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Study Design


Participants will be randomised in a 1:1 ratio into one of the following two blinded parallel treatment arms:

 

  1. Psychoactive control: 20mg oral (+ 10mg optional supplemental dose) methylphenidate-assisted therapy

 

OR

 

  1. MDMA: 120mg oral (+ 60mg optional supplemental dose) MDMA-assisted therapy

 

Up to 32 participants (16/arm) will be enrolled into the study. All participants will begin study treatment on day of randomisation.

 

For each medication-assisted therapy session, participants will undergo 2 x 90-minute therapeutic support sessions in the week preceding (e.g. to prepare for dosing, cover psychoeducational topics, explore important issues that may arise during the dosing session). Participants will also undergo 1 x 90-minute therapeutic support session the day after dosing (eg. for debrief, integration of experience, explore spiritual/other changes experienced after dosing). Dosing will occur in a comfortable clinical setting and participants will have a qualified observer/support person (physician, psychologist, nurse) with them for at least 7 hours after dosing.

 

Study Background

Symptoms of anxiety and depression are common in patients with advanced-stage cancer. Several centres have reported that one dose of the serotonergic compound psilocybin, combined with therapeutic support, improves depression and anxiety for up to 6 months in this patient group. Similarly, MDMA-assisted therapy has been shown to improve symptoms of anxiety in participants with treatment-resistant PTSD for up to 14 months or longer. A recently published Phase 2 clinical trial found a large effect size from 2 doses of MDMA for treating anxiety in participants with life-limiting illness, including advanced-stage cancer, with promising results and no significant adverse outcomes (Wolfson et al. 2020).

 

MDMA-assisted therapy

The current paradigm of psychedelic-assisted therapy has so far been contingent on a model whereby a psychedelic substance is used as a catalyst or adjuvant of psychotherapeutic work, enabling access to and processing of repressed memories and past traumas (Morgan 2020; Sessa et al 2019). MDMA-assisted therapy as developed by MAPS uses the principle of ‘inner healing intelligence’ (Mithoeffer 2017; Wolfson 2015), whereby the participant is given non-directive psychotherapeutic support to in order to find their own psychotherapeutic insight and meaning from their experience. As discussed, MDMA has a direct temporary effect of reducing the activity in the amygdala which is a fear mechanism (Kolbrich et al., 2008b). It also stimulates cortical activity (layer 5 pyramidal cells), via  5HT2a receptors, similarly to other psychedelics (Roseman et al., 2014), which have also been used in the context of end-of-life distress (Griffiths et al 2016; Ross et al 2016). With MDMA there is no reduction or clouding of consciousness, as often occurs with sedation in the palliative care setting. This allows people to address avoided psychic contents such as regrets about their life, unfinished business or past traumatic experience. It also specifically facilitates the revision of existential defences, providing the opportunity for rediscovering a sense of meaning and purpose in life. For this study, a separate study manual, based on previous work by Wolfson et al. 2015, has been created to provide a structured approach for pre- and post-MDMA-assisted therapy and psychoeducation, specific to the needs of participants in Aotearoa, New Zealand.

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WHO CAN TAKE PART IN THE STUDY?

Your patient may be eligible to participate in this study if they have advanced-stage cancer and have depression and/or anxiety. They will need to meet all the criteria to take part.
Please contact Dr Will Evans on 021848788 or email info@emmacstudynz.com if you have any questions prior to referring a patient.

Your patient cannot take part in this study if they meet any of the following exclusion criteria:

 

Inclusion criteria:

  1. Diagnosed with advanced-stage cancer (stage 3 or 4).

  2. Prognosis of at least 3 months life expectancy from the time of screening]

  3. DSM-5 diagnosis of a depressive disorder, an anxiety disorder, and/or an adjustment disorder/stress reaction.

  4. Are at least 18 years old

  5. Are able to swallow pills

  6. The participant agrees to have study visits recorded

  7. Must agree to inform the investigators within 48 hours of any medical conditions and procedures

  8. Must be willing for the investigators to communicate directly with their medical team (oncologist, GP, palliative care physician, etc).

  9. Agree to refrain from starting any new psychiatric medication and/or psychotherapy during the study period.

  10. Willing to follow restrictions and guidelines concerning consumption of food, beverages, including caffeine and nicotine the night before and just prior to medication dosing.

  11. Agree to have transportation other than driving themselves to where they are staying on the day of medication dosing.

  12. Are able and willing to be contacted via telephone for all necessary telephone contacts.

  13. If of child-bearing potential, must have a negative pregnancy test and agree to use an effective form of contraception for 10 days following the last treatment session. 

  14. Must provide a contact/support person.

  15. Are proficient in speaking and reading English.

  16. Agree to not use any medications on the prohibited medications list during the study.

  17. Agree to the lifestyle modifications illustrated below, comply with requirements for fasting, refrain from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain at the study site after each Experimental Session until cleared to be driven home after, and commit to medication dosing, therapy, and study procedures. 

 

All participants must agree to the following lifestyle modifications at enrollment and throughout the duration of the study. Participants are eligible to enroll in the study if they: 

 

  • Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessary telephone contact. 

  • Agree to not participate in any other interventional clinical trials during the duration of this study. 

 

Leading up to Experimental Sessions: 

 

  • Agree to take nothing by mouth except alcohol-free liquids after 12:00 A.M. (midnight) the evening before each Experimental Session. 

  • Refrain from the use of any psychoactive medication not approved by the research team from Baseline through Study Termination. 

  • Agree not to use caffeine or nicotine for 2 hours before and at least 6 hours after the initial dose during each Experimental Session. 

  • Are willing to comply with medication requirements per protocol. 

  • Are on a stable dose of allowable opiates for 2 weeks leading up to the Experimental Session as determined by the study physician. During this period and throughout the study, the participant will be allowed to take their usual pain medication if needed for breakthough pain. 

  • Agree that, for 1 week preceding each Experimental Session to refrain from: 

  • Taking any herbal supplement (except with prior approval of the research team). 

  • Taking any nonprescription medications (with the exception of non-steroidal anti-inflammatory medications or acetaminophen/paracetamol unless with prior approval of the research team). 

  • Taking any prescription medications (with the exception of birth control, thyroid hormones, or other medications approved by the research team). 

Exclusion criteria:

 

  1. Pregnancy or lactation.

  2. BMI < 15

  3. Recent (less than 6 months) or current use of illicit drugs including methamphetamine, heroin and synthetic cannabis.

  4.  Other non-prescribed drugs will prompt exclusion at the discretion of the study physician.

  5. Are unable to give adequate informed consent.

  6. Is taking a medication that is exclusionary or has not stopped taking an exclusionary drug for the requisite washout period.

  7. Liver function test >3 times the upper limit of normal or creatinine clearance <30 mL/min

  8. Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study, including significant cardiovascular disease (see below).

  9. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to a history of myocardial infarction, cerebrovascular accident, or aneurysm. Participants with other mild, stable chronic medical problems may be enrolled if the site physician, CI, and Study physician agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP. Examples of stable medical conditions that could be allowed include, but are not limited to diabetes mellitus (Type 2), human immunodeficiency virus (HIV) infection, gastroesophageal reflux disease (GERD), etc. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism would require exclusion.  

  10.  Have uncontrolled essential hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions). 

  11. Have any current problem which, in the opinion of the investigator or Study physician, might interfere with participation.

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