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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619001334190
Ethics application status
Approved
Date submitted
20/08/2019
Date registered
30/09/2019
Date last updated
27/10/2023
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of 3, 4-Methylenedioxymethamphetamine (MDMA)-assisted therapy on Mood and Anxiety symptoms in patients with advanced-stage Cancer Study (EMMAC Study)
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Scientific title
A double-blind, randomised trial of methylphenidate-assisted versus MDMA-assisted therapy for mood and anxiety symptoms in advanced-stage cancer patients
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Secondary ID [1]
298990
0
Nil Known
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Universal Trial Number (UTN)
U1111-1238-8911
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Trial acronym
EMMAC Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression symptoms
313993
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Anxiety symptoms
313994
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Advanced-stage cancer
313996
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Condition category
Condition code
Mental Health
312383
312383
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0
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Anxiety
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Mental Health
312384
312384
0
0
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Depression
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Cancer
312385
312385
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single dose 3, 4-Methylenedioxymethamphetamine (MDMA) in the context of MDMA-assisted therapy.
Participants will undergo a single session of MDMA assisted-therapy. Participants will receive a 120mg oral dose. If meeting criteria, an optional supplemental 60mg oral dose will be offered after 2 hours to control for inter-participant differences in dose-response. Blood pressure and pulse rate will be measured at 2 hours, if the BP is <160 and HR <110 and/or stabilising/trending down after re-assessing at 5min intervals and both therapists are in agreement, then the supplemental dose will be made available to the participant. Participants will have the option to accept or decline the supplemental dose based on whether they feel there has been a subjective adequate effect. This choice can be discussed with the therapists.
Participants will undergo 8 hours of supervised medication-assisted therapy in a comfortable non-clinical environment, with a therapeutic approach guided by the Aotearoa/New Zealand Manual for MDMA-assisted therapy treatment of depression and anxiety in the context of advanced-stage cancer.
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).
The MAPS model for MDMA-assisted therapy will be followed - two therapists will be present with the participant for all pre and post MDMA-assisted therapy sessions and will both be present for 8 hours on the dosing day. All psychotherapists will have a professional qualification in either counselling, social work, psychotherapy, psychology, nursing or medicine, or equivalent experience and have formal training and supervision with MAPS.
Sessions will be audio and video recorded for qualitative analysis and to assess therapist adherence to the therapy manual.
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Intervention code [1]
315257
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Treatment: Drugs
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Intervention code [2]
315258
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Behaviour
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Comparator / control treatment
Methylphenidate as psychoactive control in the context of medication-assisted therapy.
Participants will undergo a single session of medication assisted-therapy. Participants will receive a 20mg oral dose of methylphenidate. If meeting criteria, an optional supplemental 10mg oral dose will be offered after 2 hours to control for inter-participant differences in dose-response. Blood pressure and pulse rate will be measured at 2 hours, if the BP is <160 and HR <110 and/or stabilising/trending down after re-assessing at 5min intervals and both therapists are in agreement, then the supplemental dose will be made available to the participant. Participants will have the option to accept or decline the supplemental dose based on whether they feel there has been a subjective adequate effect. This choice can be discussed with the therapists.
Participants will undergo 8 hours of supervised medication-assisted therapy in a comfortable non-clinical environment, with a therapeutic approach guided by the Aotearoa/New Zealand Manual for MDMA-assisted therapy treatment of depression and anxiety in the context of advanced-stage cancer.
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).
The MAPS model for MDMA-assisted therapy will be followed - two therapists will be present with the participant for all pre and post medication-assisted therapy sessions and will both be present for 8 hours on the dosing day. All psychotherapists will have a professional qualification in either counselling, social work, psychotherapy, psychology, nursing or medicine, or equivalent experience and have formal training and supervision with MAPS.
Sessions will be audio and video recorded for qualitative analysis and to assess therapist adherence to the therapy manual.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change from baseline score of Montgomery Asberg Depression Scale
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Assessment method [1]
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Timepoint [1]
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [1]
373709
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Change in International Palliative Outcomes Scale (IPOS) score
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Assessment method [1]
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Timepoint [1]
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [2]
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Change in Mystical Experiences Questionnaire (MEQ30) score
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Assessment method [2]
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Timepoint [2]
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [3]
373712
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Change in FACIT Sp-12 score
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Assessment method [3]
373712
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Timepoint [3]
373712
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [4]
373713
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Change in Death Attitudes Profile Revised (ADP-R) score
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Assessment method [4]
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Timepoint [4]
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [5]
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Big Five Inventory - 2 (BFI-2) scores
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Assessment method [5]
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Timepoint [5]
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [6]
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Adverse events including nausea, teeth-clenching, muscle cramps, blurred vision, chills and excessive sweating.
Adverse events will be identified by participant report.
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Assessment method [6]
374008
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Timepoint [6]
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Any adverse events reported between dosing and day 28 (+/-3 days) post-dosing.
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Secondary outcome [7]
374678
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Suicidality assessed by Columbia-suicide severity rating scale (C-SSRS)
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Assessment method [7]
374678
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Timepoint [7]
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7 hours post-dosing, 1 day post-dosing, 3 days post-dosing (+/- 2 days), 7 days post-dosing (+/-2 days), 14 days post-dosing (+/-2 days) and day 28 (+/- 3 days) post-dosing
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Secondary outcome [8]
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Change from baseline in Hospital Anxiety and Depression Scale
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Assessment method [8]
380118
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Timepoint [8]
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [9]
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Change in Hamilton Anxiety Rating Scale (HAM-A)
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Assessment method [9]
405265
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Timepoint [9]
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [10]
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Change in Australian Karnofsky Performance Score (AKPS)
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Assessment method [10]
405268
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Timepoint [10]
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [11]
428247
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Hua Oranga score (in participants identifying as Maori)
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Assessment method [11]
428247
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Timepoint [11]
428247
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Secondary outcome [12]
428248
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Hua Oranga score (in participants identifying as Maori)
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Assessment method [12]
428248
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Timepoint [12]
428248
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Day 28 (+/-3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [13]
428249
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Watts Connectedness Scale (WCS)
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Assessment method [13]
428249
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Timepoint [13]
428249
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Day 28 (+/-3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [14]
428250
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Watts Connectedness Scale (WCS)
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Assessment method [14]
428250
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Timepoint [14]
428250
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [15]
428251
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Demoralisation Scale-II (DS-II)
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Assessment method [15]
428251
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Timepoint [15]
428251
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Secondary outcome [16]
428252
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Demoralisation Scale-II (DS-II)
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Assessment method [16]
428252
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Timepoint [16]
428252
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Day 28 (+/- 3 days) post-dosing of MDMA or methylphenidate
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Eligibility
Key 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. MADRS score > 15 and HAM-A score > 12
5. Are at least 18 years old
6. Are able to swallow pills
7. The participant agrees to have study visits recorded
8. Must agree to inform the investigators within 48 hours of any medical conditions and procedures
9. Must be willing for the investigators to communicate directly with their medical team (oncologist, GP, palliative care physician, etc).
10. Agree to refrain from starting any new psychiatric medication and/or psychotherapy during the study period.
11. Willing to follow restrictions and guidelines concerning consumption of food, beverages, including caffeine and nicotine the night before and just prior to medication dosing.
12. Agree to have transportation other than driving themselves to where they are staying on the day of medication dosing.
13. Are able and willing to be contacted via telephone for all necessary telephone contacts.
14. Must have a negative pregnancy test if able to become pregnant, and agree to use an effective form of contraception for 10 days following the last experimental session if of child-bearing potential (Effective forms of contraception include: IUD, injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones. Not of childbearing potential is defined as permanent sterilization, postmenopausal, or assigned male at birth.).
15. Must provide a contact/support person in the event of the participant being unreachable by study staff or in the event of severe emergent distress or suicidality.
16. Are proficient in speaking and reading English.
17. Agree to not use any medications on the prohibited medications list during the study.
18. 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. Medications will only be discontinued after enrollment per clinical judgment of the site physician in consultation with the prescribing physician.
• 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:
o Taking any herbal supplement (except with prior approval of the research team).
o Taking any nonprescription medications (with the exception of non-steroidal anti-inflammatory medications or acetaminophen/paracetamol unless with prior approval of the research team).
o Taking any prescription medications (with the exception of birth control, thyroid hormones, or other medications approved by the research team).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Pregnancy or lactation
2. BMI < 15
3. Recent or current use of illicit drugs including methamphetamine, heroin, and synthetic cannabinoids. Other non-prescribed drugs will prompt exclusion at the discretion of the study physician
4. Unable to give adequate informed consent
5. Upon review of past and current drugs/medication must not be taking a medication that is exclusionary (see Study Reference Manual), or has stopped taking an exclusionary drug for less than the requisite washout period (see Study Reference Manual)
6. Liver function test >3 times the upper limit of normal or creatinine clearance <30 mL/min
7. Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk for participation in the study. Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgement of the investigator will be excluded; however, history of suicide attempts is not, in itself, exclusionary. Any participant who is likely to require hospitalization related to suicidal ideation and behaviour, in the judgement of the Study physician will not be enrolled. Any participant presenting with the following on the Baseline C-SSRS will be excluded:
- Suicidal ideation score of >4 within the last month, at a frequency of once a week or more
- Suicidal ideation score of 5 within the last 6 months
- Any suicidal behaviour, including suicide attempts or preparatory acts, within the last 6 months. Participants with non-suicidal self-injurious behaviour may be included if approved by the Study physician
8. 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.
9. 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).
10. Have a history of ventricular arrhythmia at any time, other than occasional premature atrial contractions (PACs) or premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
11. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
12. Have a history of arrhythmia, other than occasional PACs or PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, and confirmed by a cardiologist.
13. Have a marked Baseline prolongation of QT/QTc interval e.g., repeated demonstration of a QTc interval >450 milliseconds (ms) in males and >460 ms in females. For transgender or non-binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for 5 or more years. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
14. Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions. Refer to Section 8.2
15. Have any current problem which, in the opinion of the investigator or Study physician, might interfere with participation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Doses will be individually packaged and numbered in appropriately labelled containers. Doses will be allocated to specific patients based on their subject number.
Enclosed treatment assignments will be serially numbered in opaque, sealed envelopes and opened sequentially after the participant’s name and other details have been written on the appropriate envelope
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to treatment group will be stratified by clinical site and gender. A computer-generated randomisation schedule will be used to assign subjects to treatments in a 1:1 ratio using blocks of 4.
Randomization will be managed via an Interactive Web Randomization System (IWRS) based on a centralized randomization schedule developed by an independent third-party vendor to maintain blinding.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Study size justification:
Wolfson’s 2020 paper on use of MDMA in anxious patients with Life Threatening Illness (mainly terminal cancer) reported a mean difference of 14.7 (SD = 14) in Spielberger Trait Anxiety Index, with n=13 treated with MDMA and 5 treated with placebo. Based on these findings and with 16 subjects in each arm, we calculate that there is 82% power to detect a difference between treatment arms, alpha = 0.05.
Statistical methods/analysis:
Data will be analysed using the Statistical Package for Social Scientists (SPSS version 14).
Analyses of primary and all secondary efficacy endpoints will be based on the Full Analysis Set (FAS) defined according to the Intention to Treat (ITT) principle. Safety analysis will be performed for the safety analysis population.
Demographic and other baseline data (including disease characteristics) will be listed in detail. Qualitative data (e.g. KS performance status) and quantitative (e.g. weight) will be summarized by appropriate descriptive statistics for each treatment group.
Change in MADRS from pre-dose to Day 28 will be assessed with a Mixed Model Repeated Measures (MMRM) method, with treatment, time and the interaction of treatment with time as fixed effects, subject as random effect and baseline MADRS as covariates. The least square mean differences between MDMA and active placebo will be presented along with a 95% confidence interval. The same approach will be undertaken for secondary and exploratory outcome scales. We also plan to include a prespecified interim analysis into the SAP. Unblinded data would be reviewed by a statistician not involved with the EMMAC study, to assist in resizing the study, if necessary. A detailed statistical analysis plan (SAP) will be developed and finalized separate from this protocol.
AEs will be categorised using NIH/NCI CTC V3.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html). AEs will be summarised by number of participants having an AE by system organ class and preferred term and treatment group. Any other information collected (e.g. severity or relationship to study treatment) will be listed and summarised by treatment group as appropriate. AEs which result in death, discontinuation or treatment delay will be presented by treatment group. Data from other tests (e.g. vital signs, ECG) will be listed along with any other information collected, as appropriate. Any statistical tests performed to explore the data will be used to highlight comparisons between treatment groups.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/02/2022
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Actual
31/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
32
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Accrual to date
1
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Final
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Recruitment outside Australia
Country [1]
21758
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New Zealand
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State/province [1]
21758
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Funding & Sponsors
Funding source category [1]
303529
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University
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Name [1]
303529
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University of Otago
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Address [1]
303529
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University of Otago
362 Leith St, North Dunedin,
Dunedin 9016
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Country [1]
303529
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New Zealand
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Funding source category [2]
315010
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Other
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Name [2]
315010
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Individual donor
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Address [2]
315010
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Private
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Country [2]
315010
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United States of America
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Funding source category [3]
315011
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Charities/Societies/Foundations
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Name [3]
315011
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Multidisciplinary Association for Psychedelic Studies (MAPS)
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Address [3]
315011
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3141 Stevens Creek Blvd #40563, San Jose, CA 95117.
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Country [3]
315011
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United States of America
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Funding source category [4]
315104
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Other
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Name [4]
315104
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Individual donor
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Address [4]
315104
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Private
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Country [4]
315104
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United States of America
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Funding source category [5]
315105
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Charities/Societies/Foundations
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Name [5]
315105
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Multidisciplinary Association for Psychedelic Studies (MAPS)
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Address [5]
315105
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3141 Stevens Creek Blvd #40563, San Jose, CA 95117.
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Country [5]
315105
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United States of America
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Primary sponsor type
University
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Name
University of Otago
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Address
362 Leith St, North Dunedin, Dunedin 9016
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Country
New Zealand
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Secondary sponsor category [1]
303594
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University
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Name [1]
303594
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University of Auckland
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Address [1]
303594
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The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
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Country [1]
303594
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304056
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Health and Disability Ethics Committee
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Ethics committee address [1]
304056
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
304056
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New Zealand
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Date submitted for ethics approval [1]
304056
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19/04/2021
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Approval date [1]
304056
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22/09/2021
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Ethics approval number [1]
304056
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21/NTB/105
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Summary
Brief summary
EMMAC is a randomised controlled trial studying the effects of MDMA-assisted therapy on mood and anxiety symptoms in advanced-stage cancer patients. Standard dose MDMA (120mg + optional 60mg) will be compared to a psychoactive placebo (Methylphenidate 20mg + optional 10mg) with both being given as a single dose. On the basis of MDMA pharmacology and recent research showing promising results with the use of psilocybin to reduce anxiety and depression in patients with advanced-stage cancer (Grob et al., 2011, Griffiths et al., 2016, Ross et al., 2016) we hypothesise that MDMA may have the potential to achieve similar positive mental health outcomes with reduced psychological risk given the differences in psychopharmacological effects.
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Trial website
https://www.emmacstudynz.com
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Paul Glue
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Address
95670
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University of Otago,
362 Leith St, North Dunedin,
Dunedin 9016
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Country
95670
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New Zealand
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Phone
95670
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+64 21 243 3372
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Fax
95670
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Email
95670
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[email protected]
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Contact person for public queries
Name
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Prof Paul Glue
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Address
95671
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University of Otago,
362 Leith St, North Dunedin,
Dunedin 9016
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Country
95671
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New Zealand
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Phone
95671
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+64 3 474 0999
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Fax
95671
0
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Email
95671
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[email protected]
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Contact person for scientific queries
Name
95672
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Prof Paul Glue
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Address
95672
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University of Otago,
362 Leith St, North Dunedin,
Dunedin 9016
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Country
95672
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New Zealand
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Phone
95672
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+64 3 474 0999
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Fax
95672
0
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Email
95672
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial after de-identification
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When will data be available (start and end dates)?
Available immediately following publication with no end date determined
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Available to whom?
Case-by-case basis at the discretion of the primary sponsor
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Available for what types of analyses?
Any purpose
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How or where can data be obtained?
Access subject to approval by Principal Investigator - can be contacted at
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4125
Study protocol
[email protected]
4126
Statistical analysis plan
[email protected]
4127
Informed consent form
[email protected]
4128
Clinical study report
[email protected]
4129
Ethical approval
[email protected]
4159
Analytic code
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF