Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: MDMA; MDMA
Intervention description: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long therapy session.; Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long therapy sessions.
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTSD; MDMA; therapy; Posttraumatic stress disorder; Israel

Summary:

      This is a study of the safety and efficacy of MDMA-assisted therapy in people with war or
      terrorism-related posttraumatic stress disorder (PTSD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Posttraumatic stress disorder arising from war or terrorism-related
             events.

          -  PTSD still remains after at last one treatment, with treatment including psychotherapy
             or pharmacotherapy.

          -  May meet criteria for a mood disorder.

          -  Must be at least 18 years old.

          -  Must be able to stop taking psychiatric medication from the start of the study until
             the two-month follow-up.

          -  May continue seeing an outside therapist during the study, but cannot increase the
             length or frequency of treatments.

          -  Must be able to follow all the rules and instructions relating to the experimental
             session, including restrictions on food and substance (alcohol and drug) consumption

          -  Must be willing to stay overnight in the clinic after each experimental session until
             the non-drug session occurring the next morning.

          -  Must be willing to be contacted by one of the researchers on a daily basis for a week
             after each experimental session.

          -  If a woman of childbearing potential, must have a negative pregnancy test and must
             agree to use an effective form of birth control.

          -  Must be able to speak and read Hebrew.

        Exclusion Criteria:

          -  Cannot have a non-war or non-terrorism event as significant contributor to PTSD
             symptoms.

          -  Cannot have history of or be diagnosed with psychotic disorder or bipolar affective
             disorder - 1.

          -  Cannot be diagnosed with dissociative identity disorder, an eating disorder with
             active purging or borderline personality disorder.

          -  Cannot have evidence or history of significant hematological, endocrine,
             cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal,
             immunocompromising, or neurological disease, including seizure disorder. (People with
             hypothyroidism who are on adequate and stable thyroid replacement will not be
             excluded).

          -  Cannot have uncontrolled hypertension, peripheral vascular disease, hepatic disease
             (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.

          -  Cannot weigh less than 50 or more than 105 kg.

          -  Cannot have used "Ecstasy" more than five times during lifetime or in the past six
             months.

          -  Cannot present a serious suicide risk or be likely to require hospitalization during
             the course of the study.

          -  Cannot require ongoing concomitant therapy with a psychotropic drug.

          -  Cannot meet DSM-IV criteria for substance abuse or dependence for any substance save
             caffeine or nicotine in the past 60 days.

          -  Unable to give adequate consent.