| Eligibility |
Criteria
Inclusion Criteria:
(As per the parent Phase III Trial - "A Multi-Site Phase 3 Study of MDMA-Assisted
Psychotherapy for PTSD" (ClinicalTrials.gov Identifier: NCT03537014)).
1. *Are at least 18 years old
2. *Are fluent in speaking an d reading the predominantly used or recognized language of
the study site
3. *Are able to swallow pills
4. Agree to have study visits recorded, including Experimental Sessions, Independent
Rater assessments, and non-drug psychotherapy sessions
5. Must provide a contact (relative, spouse, close friend or other support person) who is
willing and able to be reached
6. Must agree to inform the investigators within 48 hours of any medical conditions and
procedures
7. If of childbearing potential, must have a negative pregnancy test at study entry and
prior to each Experimental Session, and must agree to use adequate birth control
through 10 days after the last Experimental Session. Adequate birth control methods
include intrauterine device (IUD), injected or implanted hormonal methods, abstinence,
oral hormones plus a barrier contraception, vasectomized sole partner, or double
barrier contraception. Two forms of contraception are required with any barrier method
or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide,
oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential
is defined as permanent sterilization, postmenopausal, or assigned male at birth.
8. Agree to the following lifestyle modifications (described in more detail in Section
4.3 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 study, remain overnight at
the study site after each Experimental Session and be driven home after, and commit to
medication dosing, therapy, and study procedures Medical History
9. *At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of 6
months or longer
10. *At Screening, have at least severe PTSD symptoms in the last month based on PCL-5
total score of 50 or greater
11. *At Screening, may have well-controlled hypertension that has been successfully
treated with anti-hypertensive medicines, if they pass additional screening to rule
out underlying cardiovascular disease
12. *At Screening, may have asymptomatic Hepatitis C virus (HCV) that has previously
undergone evaluation and treatment as needed
13. At Baseline, have at least severe PTSD per CAPS-5 and symptoms in the last month
constituting a CAPS-5 Total Severity Score of 35 or greater.
Exclusion Criteria:
(As per the parent Phase III Trial - "A Multi-Site Phase 3 Study of MDMA-Assisted
Psychotherapy for PTSD" (ClinicalTrials.gov Identifier: NCT03537014)).
Potential participants are ineligible to enroll in the protocol if they:
1. *Are not able to give adequate informed consent
2. Are currently engaged in compensation litigation whereby financial gain would be
achieved from prolonged symptoms of PTSD or any other psychiatric disorders
3. Are likely, in the investigator's opinion and via observation during the Preparatory
Period, to be re-exposed to their index trauma or other significant trauma, lack
social support, or lack a stable living situation
4. Have used Ecstasy (material represented as containing MDMA) more than 10 times within
the last 10 years or at least once within 6 months of the first Experimental Session;
or have previously participated in a MAPS-sponsored MDMA clinical trial
5. Have any current problem which, in the opinion of the investigator or Medical Monitor,
might interfere with participation
Psychiatric History
6. *Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment
7. *Have a history of or a current primary psychotic disorder, bipolar affective disorder
type 1 assessed via MINI and confirmed via clinical interview or dissociative identity
disorder assessed via DDIS and confirmed via clinical interview
8. *Have a current eating disorder with active purging assessed via MINI and confirmed
via clinical interview
9. *Have current major depressive disorder with psychotic features assessed via MINI
10. *Meet DSM-5 criteria for active substance use disorder for any substance other than
caffeine or nicotine assessed via combination of clinical judgment, MINI, AUDIT,
DUDIT, drug test, and blood %carbohydrate-deficient transferrin (%CDT)
11. Have current Personality Disorders Cluster A (paranoid, schizoid, schizotypal),
Cluster B (antisocial, borderline, histrionic, narcissistic), or Cluster C (avoidant,
dependent, obsessive-compulsive) assessed via SCID-5-PD.
12. Any participant presenting current serious suicide risk, as determined through
psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator
will be excluded; however, history of suicide attempts is not an exclusion. Any
participant who is likely to require hospitalization related to suicidal ideation and
behavior, in the judgment of the investigator, will not be enrolled
13. Would present a serious risk to others as established through clinical interview and
contact with treating psychiatrist
14. Require ongoing concomitant therapy with a psychiatric medication with exceptions
described in Section 12.0: Concomitant Medications.
Medical History
15. *Have evidence or history of significant (controlled or uncontrolled) 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 administration (participants with hypothyroidism who are on
adequate and stable thyroid replacement will not be excluded). Note: if participants
present with a history of glaucoma, enrollment would be allowed only with the approval
of their ophthalmologist
16. *Have uncontrolled hypertension using the standard criteria of the American Heart
Association (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three
separate occasions)
17. *Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration
of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula)
18. *Have a history of additional risk factors for Torsade de pointes ( e.g., heart
failure, hypokalemia, family history of Long QT Syndrome)
19. *Require use of concomitant medications that prolong the QT/QTc interval during
Experimental Sessions. Refer to Section 12.0 Concomitant Medications.
20. *Have symptomatic liver disease
21. *Have history of hyponatremia or hyperthermia
22. *Weigh less than 48 kilograms (kg)
23. Are pregnant or nursing, or are of childbearing potential and are not practicing an
effective means of birth control
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