Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Placebo; Midomafetamine; Psychotherapy
Intervention description: Placebo with therapy administered in two blinded experimental sessions. Participants in this group in Stage 1 may take part in Stage 2.; Participants will receive MDMA-assisted therapy during two blinded experimental sessions. After unblinding, may receive a third session of open-label MDMA-assisted therapy.; Psychotherapy before and after experimental sessions.
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: PTSD; Posttraumatic stress disorder; MDMA; psychotherapy; therapy

Summary:

      The goal of this clinical trial is to compare full dose MDMA-assisted therapy to placebo with
      therapy in participants with chronic, treatment-resistant PTSD. The main question it aims to
      answer is: Does MDMA-assisted therapy versus placebo with therapy reduce PTSD symptoms?

      Participants will receive either MDMA-assisted therapy or placebo with therapy during two
      blinded experimental sessions spaced three to five weeks apart. During experimental sessions,
      participants receive an initial dose of 125 mg of MDMA, or placebo, followed by a dose of
      62.5 mg of MDMA, or placebo. During this treatment period, participants will also undergo
      non-drug preparatory therapy sessions and non-drug integration sessions.

      Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with
      therapy group to see if there is a reduction in symptoms after the treatment period. Safety
      measures will also be assessed between groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with moderate to severe PTSD;

          -  Have chronic PTSD, defined as persisting for longer than 6 months;

          -  Have treatment-resistant PTSD, meaning unable to achieve remission despite previous
             therapy or medication or discontinued treatment due to inability to tolerate previous
             therapy or medication;

          -  Are willing to refrain from taking any psychiatric medications during the study
             period;

          -  Willing to remain overnight at the study site;

          -  Agree to have transportation home after experimental sessions;

          -  Are willing to be contacted via telephone for all necessary telephone contacts;

          -  Must have a negative pregnancy test if able to bear children, and agree to use an
             effective form of birth control;

          -  Are proficient in speaking and reading English;

          -  Agree not to participate in any other interventional clinical trials during the
             duration of this study.

        Exclusion Criteria:

          -  Are pregnant or nursing, or if of child bearing potential, are not practicing an
             effective means of birth control;

          -  Weigh less than 48 kg;

          -  Are unable to give adequate informed consent;

          -  Upon review of past and current drugs/medication must not be on or have taken a
             medication that is exclusionary;

          -  Upon review of medical or psychiatric history must not have any current or past
             diagnosis that would be considered a risk to participation in the study.