| Eligibility |
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:
- 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.
- 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 milligrams of
Mercury [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] 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.
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