<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01689740</url>
  </required_header>
  <id_info>
    <org_study_id>MP-9</org_study_id>
    <nct_id>NCT01689740</nct_id>
  </id_info>
  <brief_title>Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD</brief_title>
  <official_title>A Randomized, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-assisted Psychotherapy in People With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Multidisciplinary Association for Psychedelic Studies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Multidisciplinary Association for Psychedelic Studies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 2 pilot study assessed the safety and efficacy of MDMA-assisted psychotherapy in&#xD;
      10 people with chronic, treatment-resistant posttraumatic stress disorder (PTSD), comparing&#xD;
      the effects of low and full dose MDMA as an adjunct to psychotherapy. The first two subjects&#xD;
      were enrolled in the open label full dose lead-in with 125 mg of MDMA, followed 1.5 to 2.5&#xD;
      hours later by a supplemental half-dose of 62.5 mg of MDMA. The remaining eight subjects&#xD;
      enrolled in Stage 1 of the study and received either an active placebo dose (low dose of 25&#xD;
      mg MDMA, with a supplemental dose of 12.5 mg MDMA) or a fully active dose of MDMA (125 mg,&#xD;
      with a supplemental dose of 62.5 mg MDMA) during two experimental psychotherapy session, each&#xD;
      lasting six to eight hours and scheduled three to five weeks apart. The extent of PTSD&#xD;
      symptoms was assessed at baseline and two months after the second experimental session using&#xD;
      the Clinician Administered PTSD Scale (CAPS) [Blake et al., 1995]. Subjects who enrolled in&#xD;
      Stage 1 and received the active placebo had the opportunity to enroll in Stage 2 of the study&#xD;
      and complete open-label experimental sessions with the fully active dose of MDMA on the same&#xD;
      schedule as Stage 1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop&#xD;
      after a person experiences a traumatic event, such as sexual assault, war, or any other&#xD;
      life-threatening event. PTSD is a worldwide health problem that severely reduces a person's&#xD;
      quality of life and is associated with high rates of psychiatric and medical comorbidity,&#xD;
      disability, suffering, and suicide. At least a third of PTSD patients fail to respond to&#xD;
      established PTSD psychotherapies. A wider array of effective treatments for PTSD are needed.&#xD;
&#xD;
      3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy may be a potential treatment&#xD;
      option for PTSD. MDMA is a monoamine releaser that affects serotonin, norepinephrine, and&#xD;
      dopamine. MDMA is capable of inducing unique psychopharmacological effects such as decreased&#xD;
      feelings of fear, increased feelings of wellbeing, increased sociability and extroversion,&#xD;
      increased interpersonal trust, and an alert state of consciousness. In the U.S., MDMA was&#xD;
      used as an adjunct to psychotherapy by a considerable number of psychiatrists and therapists&#xD;
      before it was placed in Schedule I in 1985 as a result of non-medical use.&#xD;
&#xD;
      This randomized, double-blind, active placebo-controlled Phase 2 pilot study investigated the&#xD;
      safety and efficacy of MDMA-assisted psychotherapy in 10 people with chronic,&#xD;
      treatment-resistant posttraumatic stress disorder (PTSD), comparing the effects of low and&#xD;
      full dose MDMA as an adjunct to psychotherapy. The first two subjects were enrolled in the&#xD;
      open label full dose lead-in with 125 mg of MDMA, followed by a supplemental half-dose of&#xD;
      62.5 mg of MDMA after 1.5 to 2.5 hours. The remaining eight subjects enrolled in Stage 1 of&#xD;
      the study and received either an active placebo dose (low dose of 25 mg MDMA with a&#xD;
      supplemental half-dose of 12.5 mg MDMA) or a fully active dose (125 mg MDMA with a&#xD;
      supplemental half-dose of 62.5 mg MDMA) during two experimental psychotherapy session, each&#xD;
      lasting six to eight hours and scheduled three to five weeks apart.&#xD;
&#xD;
      Subjects remained with their male/female co-therapist team for the entirety of the study.&#xD;
      Upon enrollment, subjects met with their therapist team for three preparatory sessions. After&#xD;
      each MDMA-assisted psychotherapy session, subjects met with their therapist team for&#xD;
      integrative psychotherapy sessions where subjects processed and connected their thoughts and&#xD;
      feelings about the experience.&#xD;
&#xD;
      The extent of PTSD symptoms was assessed at baseline and two months after the second&#xD;
      experimental session using the Clinician Administered PTSD Scale (CAPS) (Blake et al., 1995).&#xD;
      Safety measures, vital signs, and a measurement of psychological distress was assessed during&#xD;
      all experimental sessions. Blood pressure and heart rate were assessed periodically during&#xD;
      each experimental session.&#xD;
&#xD;
      Subjects who enrolled in Stage 1 and received the active placebo had the opportunity to&#xD;
      enroll in Stage 2 of the study and complete open-label experimental sessions with the fully&#xD;
      active dose of MDMA (125 mg and 62.5 mg supplemental) on the same schedule as Stage 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2013</start_date>
  <completion_date type="Actual">July 16, 2017</completion_date>
  <primary_completion_date type="Actual">April 7, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1</measure>
    <time_frame>Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)</time_frame>
    <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From End of Stage 1 to End of Stage 2</measure>
    <time_frame>End of Stage 1 to End of Stage 2</time_frame>
    <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up</measure>
    <time_frame>Baseline to 12 months post-final experimental session</time_frame>
    <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1</measure>
    <time_frame>Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)</time_frame>
    <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Depression Inventory (BDI-II) Total Score From End of Stage 1 to End of Stage 2</measure>
    <time_frame>End of Stage 1 to End of Stage 2</time_frame>
    <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up</measure>
    <time_frame>Baseline to 12 month post-final experimental session</time_frame>
    <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1</measure>
    <time_frame>Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)</time_frame>
    <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Global Assessment of Functioning (GAF) Scale From End of Stage 1 to End of Stage 2</measure>
    <time_frame>End of Stage 1 to End of Stage 2</time_frame>
    <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up</measure>
    <time_frame>Baseline to 12 months post-final experimental session</time_frame>
    <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1</measure>
    <time_frame>Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)</time_frame>
    <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From End of Stage 1 to End of Stage 2</measure>
    <time_frame>End of Stage 1 to End of Stage 2</time_frame>
    <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up</measure>
    <time_frame>Baseline to 12 months post-final experimental session</time_frame>
    <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1</measure>
    <time_frame>Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index (PSQI) From End of Stage 1 to End of Stage 2</measure>
    <time_frame>End of Stage 1 to End of Stage 2</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up</measure>
    <time_frame>Baseline to 12 months post-final experimental session</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Posttraumatic Stress Disorder (PTSD)</condition>
  <arm_group>
    <arm_group_label>Lead in: 125 mg MDMA (Open Label)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive open-label MDMA with an initial dose of 125 mg, possibly followed by a supplemental dose of 62.5 mg, during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active placebo dose MDMA (25 mg)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive initial dose of 25 mg MDMA, possibly followed by a supplemental dose of 12.5 mg, during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full dose MDMA (125 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive initial dose of 125 mg MDMA, possibly followed by a supplemental dose of 62.5 mg, during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active Placebo Dose MDMA (25 mg)</intervention_name>
    <description>Initial dose of 25 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.</description>
    <arm_group_label>Active placebo dose MDMA (25 mg)</arm_group_label>
    <other_name>3,4-methylenedioxymethamphetamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Full Dose MDMA (125 mg)</intervention_name>
    <description>Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.</description>
    <arm_group_label>Full dose MDMA (125 mg)</arm_group_label>
    <other_name>3,4-methylenedioxymethamphetamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Open Label Full Dose MDMA (125 mg)</intervention_name>
    <description>Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.</description>
    <arm_group_label>Lead in: 125 mg MDMA (Open Label)</arm_group_label>
    <other_name>3,4-methylenedioxymethamphetamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychotherapy</intervention_name>
    <description>Non-directive psychotherapy will be conducted throughout the study.</description>
    <arm_group_label>Active placebo dose MDMA (25 mg)</arm_group_label>
    <arm_group_label>Full dose MDMA (125 mg)</arm_group_label>
    <arm_group_label>Lead in: 125 mg MDMA (Open Label)</arm_group_label>
    <other_name>Manualized MDMA-assisted psychotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with chronic PTSD with a duration of 6 months or longer.&#xD;
&#xD;
          -  Have a CAPS score showing moderate to severe symptoms.&#xD;
&#xD;
          -  Had at least one unsuccessful attempt at treatment for PTSD, either with talk therapy&#xD;
             or with drugs, or stopped treatment because of inability to tolerate psychotherapy or&#xD;
             drug therapy.&#xD;
&#xD;
          -  Are at least 18 years old.&#xD;
&#xD;
          -  Generally healthy.&#xD;
&#xD;
          -  Must sign a medical release for the investigators to communicate directly with their&#xD;
             therapist and doctors.&#xD;
&#xD;
          -  Are willing to refrain from taking any psychiatric medications during the study&#xD;
             period.&#xD;
&#xD;
          -  Agree that, one week before the MDMA session, will refrain from taking all below&#xD;
             unless with prior approval of research team: herbal supplements, nonprescription&#xD;
             medications (with the exception of nonsteroidal anti-inflammatory drugs or&#xD;
             acetaminophen, any prescription medications, with the exception of birth control&#xD;
             pills, thyroid hormone, or other medications;&#xD;
&#xD;
          -  Are willing to follow restrictions and guidelines concerning consumption of food,&#xD;
             beverages. and nicotine the night before and just prior to each experimental session.&#xD;
&#xD;
          -  Are willing to remain overnight at the study site.&#xD;
&#xD;
          -  Are willing to be contacted via telephone for all necessary telephone contacts.&#xD;
&#xD;
          -  Must have a negative pregnancy test if able to bear children, and agree to use an&#xD;
             effective form of birth control.&#xD;
&#xD;
          -  Agree not to participate in any other clinical trial for the duration of this clinical&#xD;
             trial, including the follow-up period.&#xD;
&#xD;
          -  Are proficient in speaking and reading Hebrew.&#xD;
&#xD;
          -  Agree to have all psychotherapy sessions recorded to audio/video.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are pregnant or nursing, or if they can have children and are not practicing an&#xD;
             effective means of birth control.&#xD;
&#xD;
          -  Weigh less than 48 kg.&#xD;
&#xD;
          -  Are abusing illegal drugs.&#xD;
&#xD;
          -  Are unable to give adequate informed consent.&#xD;
&#xD;
          -  Upon review of past and current drugs/medication must not be on or have taken a&#xD;
             medication that is exclusionary.&#xD;
&#xD;
          -  Upon review of medical or psychiatric history must not have any current or past&#xD;
             diagnosis that would be considered a risk to participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moshe Kotler</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beer Yaakov Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beer Yaakov Hospital</name>
      <address>
        <city>Be'er Ya'aqov</city>
        <zip>70350</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995 Jan;8(1):75-90. doi: 10.1007/BF02105408.</citation>
    <PMID>7712061</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>August 14, 2020</results_first_submitted>
  <results_first_submitted_qc>October 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 30, 2020</results_first_posted>
  <disposition_first_submitted>August 15, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>August 16, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 21, 2018</disposition_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MDMA</keyword>
  <keyword>Posttraumatic stress disorder</keyword>
  <keyword>PTSD</keyword>
  <keyword>Israel</keyword>
  <keyword>psychotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>N-Methyl-3,4-methylenedioxyamphetamine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 27, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT01689740/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT01689740/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT01689740/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited through printed ads, internet ads, referrals from other psychiatrists, psychotherapists or physicians, through the Israeli Defense Forces (IDF) and through word of mouth.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
          <description>Open label: Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.&#xD;
125 mg MDMA (open label): Initial dose of MDMA administered orally at the start of each of two psychotherapy sessions, supplement administered 1.5 to 2.5 hours later.&#xD;
Psychotherapy: Psychotherapy provided throughout course of main study</description>
        </group>
        <group group_id="P2">
          <title>Active Placebo Dose MDMA and Psychotherapy</title>
          <description>Participants receive initial doses of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.&#xD;
Active placebo dose MDMA: Initial dose of 25 mg MDMA administered orally at the start of each of two separate psychotherapy sessions scheduled three to five weeks apart possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.&#xD;
Psychotherapy: Psychotherapy provided throughout course of main study</description>
        </group>
        <group group_id="P3">
          <title>Full Dose MDMA and Psychotherapy</title>
          <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.&#xD;
Full dose MDMA: Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions scheduled three to five weeks apart. In each case, it may be followed 1.5 to 2.5 hours later with 62.5 mg MDMA.&#xD;
Psychotherapy: Psychotherapy provided throughout course of main study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
          <description>Participants receive open MDMA with an initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
        </group>
        <group group_id="B2">
          <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
          <description>Participants receive initial doses of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
        </group>
        <group group_id="B3">
          <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
          <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>White/Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Middle Eastern</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1</title>
        <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
        <time_frame>Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)</time_frame>
        <population>Intent-to-Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1</title>
          <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
          <population>Intent-to-Treat (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.0" spread="9.90"/>
                    <measurement group_id="O2" value="-9.0" spread="15.62"/>
                    <measurement group_id="O3" value="-34.6" spread="16.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From End of Stage 1 to End of Stage 2</title>
        <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
        <time_frame>End of Stage 1 to End of Stage 2</time_frame>
        <population>Crossover set</population>
        <group_list>
          <group group_id="O1">
            <title>Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover</title>
            <description>Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.&#xD;
Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From End of Stage 1 to End of Stage 2</title>
          <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
          <population>Crossover set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.0" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up</title>
        <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
        <time_frame>Baseline to 12 months post-final experimental session</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up</title>
          <description>The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.0" spread="14.14"/>
                    <measurement group_id="O2" value="-34.5" spread="20.51"/>
                    <measurement group_id="O3" value="-48.8" spread="20.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1</title>
        <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
        <time_frame>Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1</title>
          <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.0" spread="2.83"/>
                    <measurement group_id="O2" value="0.33" spread="4.73"/>
                    <measurement group_id="O3" value="-17.0" spread="12.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Beck Depression Inventory (BDI-II) Total Score From End of Stage 1 to End of Stage 2</title>
        <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
        <time_frame>End of Stage 1 to End of Stage 2</time_frame>
        <population>Crossover set</population>
        <group_list>
          <group group_id="O1">
            <title>Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover</title>
            <description>Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.&#xD;
Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Beck Depression Inventory (BDI-II) Total Score From End of Stage 1 to End of Stage 2</title>
          <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
          <population>Crossover set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.0" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up</title>
        <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
        <time_frame>Baseline to 12 month post-final experimental session</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up</title>
          <description>Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.0" spread="5.66"/>
                    <measurement group_id="O2" value="-3.5" spread="4.95"/>
                    <measurement group_id="O3" value="-18.4" spread="11.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1</title>
        <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
        <time_frame>Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1</title>
          <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="21.21"/>
                    <measurement group_id="O2" value="-2.33" spread="8.74"/>
                    <measurement group_id="O3" value="18.2" spread="11.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Global Assessment of Functioning (GAF) Scale From End of Stage 1 to End of Stage 2</title>
        <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
        <time_frame>End of Stage 1 to End of Stage 2</time_frame>
        <population>Crossover set</population>
        <group_list>
          <group group_id="O1">
            <title>Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover</title>
            <description>Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.&#xD;
Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Global Assessment of Functioning (GAF) Scale From End of Stage 1 to End of Stage 2</title>
          <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
          <population>Crossover set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up</title>
        <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
        <time_frame>Baseline to 12 months post-final experimental session</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up</title>
          <description>The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread="7.07"/>
                    <measurement group_id="O2" value="-2.0" spread="4.24"/>
                    <measurement group_id="O3" value="26.6" spread="10.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1</title>
        <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
        <time_frame>Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1</title>
          <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.0" spread="5.66"/>
                    <measurement group_id="O2" value="1.33" spread="13.43"/>
                    <measurement group_id="O3" value="-17.4" spread="9.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From End of Stage 1 to End of Stage 2</title>
        <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
        <time_frame>End of Stage 1 to End of Stage 2</time_frame>
        <population>Crossover set</population>
        <group_list>
          <group group_id="O1">
            <title>Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover</title>
            <description>Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.&#xD;
Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From End of Stage 1 to End of Stage 2</title>
          <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
          <population>Crossover set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.0" spread="7.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up</title>
        <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
        <time_frame>Baseline to 12 months post-final experimental session</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up</title>
          <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.0" spread="0"/>
                    <measurement group_id="O2" value="-10" spread="9.90"/>
                    <measurement group_id="O3" value="-20.4" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1</title>
        <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
        <time_frame>Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1</title>
          <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="6.36"/>
                    <measurement group_id="O2" value="1.0" spread="5.29"/>
                    <measurement group_id="O3" value="-1.8" spread="4.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pittsburgh Sleep Quality Index (PSQI) From End of Stage 1 to End of Stage 2</title>
        <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
        <time_frame>End of Stage 1 to End of Stage 2</time_frame>
        <population>Crossover set</population>
        <group_list>
          <group group_id="O1">
            <title>Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover</title>
            <description>Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.&#xD;
Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pittsburgh Sleep Quality Index (PSQI) From End of Stage 1 to End of Stage 2</title>
          <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
          <population>Crossover set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up</title>
        <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
        <time_frame>Baseline to 12 months post-final experimental session</time_frame>
        <population>Intent-to-Treat set (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
            <description>Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
          </group>
          <group group_id="O2">
            <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose MDMA (125 mg) and Psychotherapy</title>
            <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up</title>
          <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.</description>
          <population>Intent-to-Treat set (ITT)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="3.54"/>
                    <measurement group_id="O2" value="-2.0" spread="4.24"/>
                    <measurement group_id="O3" value="-2.2" spread="5.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline to study completion (approximately 18 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lead in: 125 mg MDMA (Open Label) and Psychotherapy</title>
          <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.</description>
        </group>
        <group group_id="E2">
          <title>Active Placebo Dose MDMA (25 mg) and Psychotherapy (Stage 1)</title>
          <description>Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
        </group>
        <group group_id="E3">
          <title>Full Dose MDMA (125 mg) and Psychotherapy (Stage 1)</title>
          <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
        </group>
        <group group_id="E4">
          <title>Full Dose MDMA (125 mg) and Psychotherapy (Stage 2)</title>
          <description>Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Posttraumatic stress disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Anger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Exposure to violent event</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Berra Yazar-Klosinski, PhD / Chief Scientific Officer</name_or_title>
      <organization>Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp.</organization>
      <phone>(831) 429-6362</phone>
      <email>trialdata@mapsbcorp.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01689740
org study id: MP-9
nct id: NCT01689740
lead sponsor: 
has dmc: No
This Phase 2 pilot study assessed the safety and efficacy of MDMA-assisted psychotherapy in
      10 people with chronic, treatment-resistant posttraumatic stress disorder (PTSD), comparing
      the effects of low and full dose MDMA as an adjunct to psychotherapy. The first two subjects
      were enrolled in the open label full dose lead-in with 125 mg of MDMA, followed 1.5 to 2.5
      hours later by a supplemental half-dose of 62.5 mg of MDMA. The remaining eight subjects
      enrolled in Stage 1 of the study and received either an active placebo dose (low dose of 25
      mg MDMA, with a supplemental dose of 12.5 mg MDMA) or a fully active dose of MDMA (125 mg,
      with a supplemental dose of 62.5 mg MDMA) during two experimental psychotherapy session, each
      lasting six to eight hours and scheduled three to five weeks apart. The extent of PTSD
      symptoms was assessed at baseline and two months after the second experimental session using
      the Clinician Administered PTSD Scale (CAPS) [Blake et al., 1995]. Subjects who enrolled in
      Stage 1 and received the active placebo had the opportunity to enroll in Stage 2 of the study
      and complete open-label experimental sessions with the fully active dose of MDMA on the same
      schedule as Stage 1.
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop
      after a person experiences a traumatic event, such as sexual assault, war, or any other
      life-threatening event. PTSD is a worldwide health problem that severely reduces a person's
      quality of life and is associated with high rates of psychiatric and medical comorbidity,
      disability, suffering, and suicide. At least a third of PTSD patients fail to respond to
      established PTSD psychotherapies. A wider array of effective treatments for PTSD are needed.

      3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy may be a potential treatment
      option for PTSD. MDMA is a monoamine releaser that affects serotonin, norepinephrine, and
      dopamine. MDMA is capable of inducing unique psychopharmacological effects such as decreased
      feelings of fear, increased feelings of wellbeing, increased sociability and extroversion,
      increased interpersonal trust, and an alert state of consciousness. In the U.S., MDMA was
      used as an adjunct to psychotherapy by a considerable number of psychiatrists and therapists
      before it was placed in Schedule I in 1985 as a result of non-medical use.

      This randomized, double-blind, active placebo-controlled Phase 2 pilot study investigated the
      safety and efficacy of MDMA-assisted psychotherapy in 10 people with chronic,
      treatment-resistant posttraumatic stress disorder (PTSD), comparing the effects of low and
      full dose MDMA as an adjunct to psychotherapy. The first two subjects were enrolled in the
      open label full dose lead-in with 125 mg of MDMA, followed by a supplemental half-dose of
      62.5 mg of MDMA after 1.5 to 2.5 hours. The remaining eight subjects enrolled in Stage 1 of
      the study and received either an active placebo dose (low dose of 25 mg MDMA with a
      supplemental half-dose of 12.5 mg MDMA) or a fully active dose (125 mg MDMA with a
      supplemental half-dose of 62.5 mg MDMA) during two experimental psychotherapy session, each
      lasting six to eight hours and scheduled three to five weeks apart.

      Subjects remained with their male/female co-therapist team for the entirety of the study.
      Upon enrollment, subjects met with their therapist team for three preparatory sessions. After
      each MDMA-assisted psychotherapy session, subjects met with their therapist team for
      integrative psychotherapy sessions where subjects processed and connected their thoughts and
      feelings about the experience.

      The extent of PTSD symptoms was assessed at baseline and two months after the second
      experimental session using the Clinician Administered PTSD Scale (CAPS) (Blake et al., 1995).
      Safety measures, vital signs, and a measurement of psychological distress was assessed during
      all experimental sessions. Blood pressure and heart rate were assessed periodically during
      each experimental session.

      Subjects who enrolled in Stage 1 and received the active placebo had the opportunity to
      enroll in Stage 2 of the study and complete open-label experimental sessions with the fully
      active dose of MDMA (125 mg and 62.5 mg supplemental) on the same schedule as Stage 1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1
time frame: Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)
description: The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
measure: Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From End of Stage 1 to End of Stage 2
time frame: End of Stage 1 to End of Stage 2
description: The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
measure: Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up
time frame: Baseline to 12 months post-final experimental session
description: The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
measure: Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1
time frame: Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)
description: Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
measure: Change in Beck Depression Inventory (BDI-II) Total Score From End of Stage 1 to End of Stage 2
time frame: End of Stage 1 to End of Stage 2
description: Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
measure: Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up
time frame: Baseline to 12 month post-final experimental session
description: Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
measure: Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1
time frame: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
description: The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
measure: Change in Global Assessment of Functioning (GAF) Scale From End of Stage 1 to End of Stage 2
time frame: End of Stage 1 to End of Stage 2
description: The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
measure: Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up
time frame: Baseline to 12 months post-final experimental session
description: The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
measure: Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1
time frame: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
description: The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
measure: Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From End of Stage 1 to End of Stage 2
time frame: End of Stage 1 to End of Stage 2
description: The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
measure: Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up
time frame: Baseline to 12 months post-final experimental session
description: The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
measure: Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1
time frame: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
description: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
measure: Change in Pittsburgh Sleep Quality Index (PSQI) From End of Stage 1 to End of Stage 2
time frame: End of Stage 1 to End of Stage 2
description: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
measure: Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up
time frame: Baseline to 12 months post-final experimental session
description: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
arm group label: Lead in: 125 mg MDMA (Open Label)
arm group type: Experimental
description: Participants receive open-label MDMA with an initial dose of 125 mg, possibly followed by a supplemental dose of 62.5 mg, during two psychotherapy sessions scheduled 3-5 weeks apart.
arm group label: Active placebo dose MDMA (25 mg)
arm group type: Placebo Comparator
description: Participants receive initial dose of 25 mg MDMA, possibly followed by a supplemental dose of 12.5 mg, during two psychotherapy sessions scheduled 3-5 weeks apart.
arm group label: Full dose MDMA (125 mg)
arm group type: Experimental
description: Participants receive initial dose of 125 mg MDMA, possibly followed by a supplemental dose of 62.5 mg, during two psychotherapy sessions scheduled 3-5 weeks apart.
intervention type: Drug
intervention name: Active Placebo Dose MDMA (25 mg)
description: Initial dose of 25 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.
arm group label: Active placebo dose MDMA (25 mg)
other name: 3,4-methylenedioxymethamphetamine
intervention type: Drug
intervention name: Full Dose MDMA (125 mg)
description: Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
arm group label: Full dose MDMA (125 mg)
other name: 3,4-methylenedioxymethamphetamine
intervention type: Drug
intervention name: Open Label Full Dose MDMA (125 mg)
description: Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
arm group label: Lead in: 125 mg MDMA (Open Label)
other name: 3,4-methylenedioxymethamphetamine
intervention type: Behavioral
intervention name: Psychotherapy
description: Non-directive psychotherapy will be conducted throughout the study.
arm group label: Active placebo dose MDMA (25 mg)
arm group label: Full dose MDMA (125 mg)
arm group label: Lead in: 125 mg MDMA (Open Label)
other name: Manualized MDMA-assisted psychotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Moshe Kotler
role: Principal Investigator
affiliation: Beer Yaakov Hospital
facility: 
country: Israel
citation: Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995 Jan;8(1):75-90. doi: 10.1007/BF02105408.
PMID: 7712061
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: N-Methyl-3,4-methylenedioxyamphetamine
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 