A Multi-site Expanded Access Program for... — Clinical Trial Details

Open-label expanded access programme providing MDMA-assisted psychotherapy to treatment-resistant PTSD patients who cannot join other MDMA trials; intended to provide safety and tolerability data and treat up to 50 patients.

Participants receive 3 preparatory non-drug therapy sessions, up to 3 open-label MDMA-assisted therapy sessions (initial 80–120 mg with supplemental 40 or 60 mg 1.5–2 hours later as indicated) each followed by overnight stay and 3 integrative 90-minute sessions.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
At Screening, meet criteria for PTSD diagnosis according to medical history and clinical interview and have at least moderate PTSD symptoms in the last month.
Have had at least two unsuccessful attempts at treatment for PTSD. Treatment attempts can consist of adequate dose and duration of medication treatment (at least 3 months of Paroxetine or Sertraline or other SSRI at dosages recommended in the package insert) or adequate duration of therapy treatment (at least 12 sessions of psychotherapy) or any combination of these two categories.
Are at least 18 years old.
Are fluent in speaking and reading a recognized language of the expanded access site.
Are able to swallow pills.
Agree to have study visits recorded, if applicable, including Experimental Sessions and non-drug therapy sessions.
Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a patient becoming suicidal or unreachable.
Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
If a patient has the ability to become pregnant, they must have a negative pregnancy test at program entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the protocol without prior approval of the medical monitor, remain overnight at the site, or nearby location, after each Experimental Session and be driven home on the following day, and commit to medication dosing, therapy, and program procedures.
May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening within the past year to rule out underlying cardiovascular disease.
May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
May have current alcohol or substance use disorder if patient meets criteria for early remission prior to enrollment.
May have a history of or current Diabetes Mellitus (Type 1 or Type 2), if the patient passes additional screening to rule out underlying cardiovascular disease.
May have hypothyroidism if taking adequate and stable thyroid replacement medication.
May have a history of, or current glaucoma, if approval for program participation is received from an ophthalmologist.

Exclusion Criteria

Exclusion Criteria:
Are not able to give adequate informed consent.
Have any current problem which, in the opinion of the investigator or medical monitor, might interfere with participation.
Have used Ecstasy (material represented as containing MDMA) within three months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial.
In the investigator's opinion, lack a stable living situation or supportive family/network.
Have evidence or history of significant medical and psychiatric disorders.
Any patient presenting current serious suicide risk.
Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
Have 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.
Have a history of ventricular arrhythmia, other than occasional PVCs in the absence of ischemic heart disease, at any time or with a history of supraventricular arrhythmia within the past year.
Have a diagnosis of uncontrolled hypertension using the standard criteria of the American Heart Association for Stage 2 hypertension (values of 140/90 mmHg or higher assessed on three separate occasions).
Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males or >460 ms in females corrected by Fridericia's formula).
Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions.
Have symptomatic liver disease or have significant liver enzyme elevation.
Have a history of HCV that has not been evaluated and treated successfully if treatment is indicated.
Have history of hyponatremia or hyperthermia.
Are pregnant or nursing, or able to become pregnant and are not practicing an effective means of contraception.

Company

Product

Legal

A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

MDMA-assisted therapy

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details