A study to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with posttraumatic stress disorder

Phase 2

Recruiting

• Conditions: Mental Health - Other mental health disorders; Posttraumatic Stress Disorder

• Registration Number: ACTRN12623000838617
• Lead Sponsor: Emyria Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-04
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Incidence and severity of adverse events assessed continuously throughout the 12-week treatment period];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. [Reviewed at the the completion of the 12-week treatment period and at the End of study (12 months post the final treatment session)]