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Trial registered on ANZCTR


Registration number
ACTRN12623000838617
Ethics application status
Approved
Date submitted
7/07/2023
Date registered
4/08/2023
Date last updated
4/08/2023
Date data sharing statement initially provided
4/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with posttraumatic stress disorder
Scientific title
An open label study to investigate the safety and feasibility of delivering 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy to patients with posttraumatic stress disorder
Secondary ID [1] 310075 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 330616 0
Condition category
Condition code
Mental Health 327451 327451 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants enrolled in the study will undergo 3 cycles of treatment over a 12-week period, preceded by two Preparatory Sessions (approx. 2 hours each) where the therapy team will work with the participant to prepare for the treatment sessions, complete baseline questionnaires and promote a safe setting for confronting trauma related memories. Within each treatment cycle, participants will attend a full-day Treatment Session (approx. 8 hours each) where they will be administered an initial dose of 87mg of MDMA with a supplemental half-dose of 43.5mg MDMA, unless contraindicated, together with psychotherapy. After each Treatment Session, participants will attend three Integration Sessions, conducted 24 hours, 3-14 days and 20-34 days post each treatment session, of non-drug psychotherapy (approx. 1.5 hours each) where the treatment team will discuss and review with the participant the events that occurred during the Treatment Session. At the completion of the third Treatment Cycle, participants will enter the Follow-Up period, with Visits at 3, 6 and 12 months after their final Treatment Session. The treatment sessions will be delivered by a 2-person therapy team, which will consisting of at least one licensed psychotherapy provider and adherence to the study requirements will be assessed through regular contact with the participant.
Intervention code [1] 326478 0
Treatment: Drugs
Intervention code [2] 326529 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335313 0
To determine the safety and tolerability of this treatment through the assessment of adverse events via patient reported symptoms, clinician review and completion of study-specific questionnaires. Possible adverse events may include headache, fatigue and nausea.
Timepoint [1] 335313 0
Incidence and severity of adverse events assessed continuously throughout the 12-week treatment period
Primary outcome [2] 335314 0
To determine the feasibility of delivering this treatment in an Australian setting by assessing the cost and clinical resources required to deliver this treatment. This will include review of staff and facility resources required to complte the treatment.
Timepoint [2] 335314 0
Reviewed at the the completion of the 12-week treatment period and at the End of study (12 months post the final treatment session)
Secondary outcome [1] 423878 0
To determine the effect of this treatment on PTSD symptomatology on patients with a diagnosis of PTSD via completion of the PCL-5 questionnaire (PTSD Checklist for DSM-5)
Timepoint [1] 423878 0
Change in PCL-5 questionnaire score from baseline and following 12 weeks of treatment
Secondary outcome [2] 423879 0
To determine the effect of this treatment on symptoms of anxiety and depression via completion of the Depression, Anxiety and Stress Scale (DASS-21) questionnaire
Timepoint [2] 423879 0
Change in patient self-reported DASS-21 questionnaire from baseline and following 12 weeks of treatment
Secondary outcome [3] 423880 0
To determine the effect of this treatment on quality of life via completion of the RAND Short Form-36 (SF-36) questionnaire
Timepoint [3] 423880 0
Change in patient self-reported RAND SF- 36 questionnaire from baseline and following 12 weeks of treatment
Secondary outcome [4] 423881 0
To determine the effect of this treatment on workplace productivity via completion of the Health and Work Performance Absenteeism and Presenteeism Short Form questionnaire
Timepoint [4] 423881 0
Change in self-reported Health and Work Performance Absenteeism and Presenteeism Short Form questionnaire from baseline and following 12 weeks of treatment
Secondary outcome [5] 423882 0
To determine the effect of this treatment on healthcare utilisation via completion of the Healthcare Access Survey
Timepoint [5] 423882 0
Change in self-reported Healthcare Access Survey from baseline and following 12 weeks of treatment
Secondary outcome [6] 423883 0
To determine the effect of this treatment on patient’s impression of change via completion of the Patient Global Impression of Change questionnaire
Timepoint [6] 423883 0
Change in self-reported Patient Global Impression of Change questionnaire following 12 weeks of treatment
Secondary outcome [7] 423884 0
To determine the effect of this treatment on the treating clinician’s impression of change via completion of the Clinician Global Impression questionnaire
Timepoint [7] 423884 0
Change in Clinician Global Impression questionnaire from baseline and following 12 weeks of treatment
Secondary outcome [8] 423885 0
To determine the effect of secondary traumatic stressors on treatment efficacy via completion of the Change in Life Events Checklist (LEC-5) score
Timepoint [8] 423885 0
Change in Life Events Checklist (LEC-5) score as a covariate of the PCL-5 Total Score from baseline and following 12 weeks of treatment

Eligibility
Key inclusion criteria
- Can provide a support person (relative, spouse, close friend, or other support person) who is willing and able to stay overnight with the participant following each Treatment Session, and who can be reached by the investigators in the event of a participant becoming suicidal or unreachable.
- If of childbearing potential, has a negative pregnancy test at study entry and prior to each Treatment Session, and agrees to use adequate birth control through 10 days after the last Treatment Session
- At Screening, has PTSD as diagnosed by a psychiatrist, with a symptom duration of 12 months or longer.
- At Screening, is an active patient at the study site.
- Has tried at least two conventional treatments (e.g. two forms of psychotherapy, two medications or a combination of the two) under the supervision of a healthcare professional.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has borderline personality disorder with a history of associated psychotic decompensations.
- Has evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA.
- Has a history of or current Diabetes Mellitus (Type 1 or 2), hypothyroidism or glaucoma unless approval for study participation is received from the patient’s treating specialist.
- Has active alcohol or substance use disorder.
- Presents current suicide risk (i.e. current plan and intent).
- Has symptomatic liver disease or has significant liver enzyme elevation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/07/2023
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
5
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 314241 0
Commercial sector/Industry
Name [1] 314241 0
Emyria Ltd
Country [1] 314241 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Emyria Ltd
Address
D2 661 Newcastle St, Leederville WA 6007
Country
Australia
Secondary sponsor category [1] 316173 0
None
Name [1] 316173 0
Address [1] 316173 0
Country [1] 316173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313359 0
Bellberry Ltd
Ethics committee address [1] 313359 0
Ethics committee country [1] 313359 0
Australia
Date submitted for ethics approval [1] 313359 0
28/04/2023
Approval date [1] 313359 0
07/06/2023
Ethics approval number [1] 313359 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127874 0
Dr Jonathan Laugharne
Address 127874 0
Pax Centre
160B Cambridge St, West Leederville WA 6007
Country 127874 0
Australia
Phone 127874 0
+610894555440
Fax 127874 0
Email 127874 0
jl@paxcentre.com.au
Contact person for public queries
Name 127875 0
Adrienne Smith
Address 127875 0
Emyria Ltd
D2 661 Newcastle Street, Leederville, Western Australia 6007
Country 127875 0
Australia
Phone 127875 0
+610865592800
Fax 127875 0
Email 127875 0
asmith@emyria.com
Contact person for scientific queries
Name 127876 0
Adrienne Smith
Address 127876 0
Emyria Ltd
D2 661 Newcastle Street, Leederville, Western Australia 6007
Country 127876 0
Australia
Phone 127876 0
+610865592800
Fax 127876 0
Email 127876 0
asmith@emyria.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Intellectual property


What supporting documents are/will be available?

No Supporting Document Provided



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.