Randomized, Double-blind, Active-placebo Controlled Study of MDMA-assisted Psychotherapy in People With Chronic PTSD

Inclusion Criteria:

• Diagnosed with chronic PTSD with a duration of at least six months;
• Have a CAPS score of 50 or higher, indicating moderate to severe PTSD symptoms;
• at least one unsuccessful attempt at treatment for PTSD with psychotherapy (talk therapy) or with drugs such as SSRIs, SNRIs or MAOIs;
• Are at least 18 years old;
• If in ongoing psychotherapy at the time of recruitment, must sign a release permitting the investigators to communicate directly with their therapist, and May not change therapists, increase the frequency of therapy or commence any new type of therapy until after the evaluation session at the end of Stage 1 or 2, as applicable;
• Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control. Any psychiatric drugs will be tapered in an appropriate fashion to avoid withdrawal effects;
• agree that, one week before the MDMA session, will refrain from taking all below unless with prior approval of research team: herbal supplements, nonprescription medications (with the exception of nonsteroidal anti-inflammatory drugs or acetaminophen,any prescription medications, with the exception of birth control pills, thyroid hormone, or other medications;
• willing to follow restrictions and guidelines concerning consumption of food, beverages and nicotine the night before and just prior to each MDMA session;
• are willing to remain overnight at the study site;
• Spontaneously Reported Reactions In MP-1 During 8 Days After Experimental Session 3;
• are willing to be contacted via telephone for all necessary telephone contacts;
• must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;
• Agree not to participate in any other clinical trial for the duration of this clinical trial, including the follow up period;
• Are proficient in speaking and reading Hebrew;
• Agree to have all psychotherapy sessions recorded to audio/video.

Exclusion Criteria:

• are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
• have past or current psychotic disorder, bipolar affective disorder type 1, dissociative identity disorder or an eating disorder with active purging;
• 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.
• Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions);
• Have liver disease;
• Have history of Diabetes Type I or II;
• Have history of hyponatremia or hyperthermia;
• Weigh less than 48 kg;
• Would present a serious suicide risk or who are likely to require hospitalization during the course of the study;
• Have used "Ecstasy" (material represented as containing MDMA) more than five times or at least once within 6 months of the MDMA session;
• Require ongoing concomitant therapy with a psychiatric drug, including SSRIs, SNRIs, or MAOIs;
• Diagnosed with substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days;
• Have glaucoma, significant atherosclerosis or hyperthyroidism;
• Have any current problem, which in the opinion of the investigator or medical monitor, might interfere with participation in the study;
• Are not able to give adequate informed consent.