Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Low dose MDMA; Medium dose MDMA; Full dose MDMA; Therapy
Intervention description: 30 mg MDMA administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later; 75 mg MDMA administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 37.5 mg MDMA 1.5 to 2 hours later; 125 mg MDMA administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2 hours later; Non-directive therapy during each session
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: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MDMA; Therapy; Veterans; Posttraumatic Stress Disorder

Summary:

      This study is designed to provide information on whether therapy ("talk therapy") combined
      with the drug MDMA is safe and helpful for subjects with posttraumatic stress disorder
      (PTSD). The study will compare the effects of a low, a medium and a full dose of MDMA on
      symptoms of PTSD in 24 veterans, firefighters or police officers. MDMA dose will be assigned
      at random, and the investigators and the subject will not know the dose given. The
      researchers will also investigate depression symptoms. The researchers believe that the full
      dose of MDMA will produce a greater reduction in PTSD symptoms than the two lower doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be diagnosed with chronic PTSD, duration of 6 months or longer resulting from
             traumatic experience during military service;

          -  Have a CAPS score showing moderate to severe PTSD symptoms;

          -  Have had at least one unsuccessful attempt at treatment for PTSD either with talk
             therapy or with drugs, or discontinuing treatment because of inability to tolerate
             psychotherapy or drug therapy.

          -  Are at least 18 years old;

          -  Must be generally healthy;

          -  Must sign a medical release for the investigators to communicate directly with their
             therapist and doctors;

          -  Are willing to refrain from taking any psychiatric medications during the study
             period;

          -  Willing to follow restrictions and guidelines concerning consumption of food,
             beverages, and nicotine the night before and just prior to each experimental session;

          -  Willing to remain overnight at the study site;

          -  Agree to have transportation other than driving themselves home or to where they are
             staying after the integrative session on the day after the MDMA session;

          -  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;

          -  Must provide a contact in the event of a participant becoming suicidal;

          -  Are proficient in speaking and reading English;

          -  Agree to have all clinic visit sessions recorded to audio and video

          -  Agree not to participate in any other interventional clinical trials during the
             duration of this study.

        Exclusion Criteria:

        5.3.2 Exclusion Criteria:

          -  Are pregnant or nursing, or if a woman who can have children, those who are not
             practicing an effective means of birth control;

          -  Weigh less than 48 kg;

          -  Are abusing illegal drugs;

          -  Are unable to give adequate informed consent;

          -  Upon review of past and current drugs/medication must not be on or have taken a
             medication that is exclusionary.

          -  Upon review of medical or psychiatric history must not have any current or past
             diagnosis that would be considered a risk to participation in the s