ActivePhase 2ACTRN12623000838617

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

An open label study to investigate the safety and feasibility of delivering 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy to patients with posttraumatic stress disorder

Sponsor

Emyria Ltd

Enrollment

5 participants

Start Date

Jul 6, 2023

Study Type

Interventional

Conditions

Posttraumatic Stress Disorder

Summary

Posttraumatic stress disorder (PTSD) is a serious debilitating disorder that negatively impacts a person’s daily life, and can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, high-cost healthcare utilisation, increased depression and other mental and physical health co-morbidities. MDMA-assisted therapy has shown to be effective for the treatment of PTSD as it reduces defenses and fear of emotional injury, enhances communication, and increase empathy and compassion. The subjective effects of MDMA create a productive psychological state that enhances the therapeutic process. The purpose of this study is to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with PTSD.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria5

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 Criteria6

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.

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Interventions

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.