A study to investigate the safety and feasibility... — Clinical Trial Details

Participants receive two preparatory sessions (~2 hours each), then three full-day treatment sessions (~8 hours each) over 12 weeks; each treatment session includes an initial 87 mg oral MDMA dose with a supplemental half-dose (43.5 mg) administered in-session unless contraindicated.

Each treatment session is followed by three integration sessions (24 hours; 3–14 days; 20–34 days post-session, ~1.5 hours each). Outcomes include safety/tolerability (adverse events) and change in PTSD symptoms measured by PCL-5; follow-up visits occur at 3, 6 and 12 months after final session.

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.

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

MDMA-assisted therapy

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details