MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Midomafetamine; Lactose placebo pill; Therapy
Intervention description: 125 mg followed by a supplemental half-dose of 62.5 mg; 125 mg followed by a supplemental half-dose of 62.5 mg; Non-directive therapy provided by a team of two co-therapists
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: MDMA; Methylenedioxymethamphetamine; PTSD; psychotherapy

Summary:

      The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy
      in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main
      question it aims to answer is: Is there a reduction in PTSD symptoms among people given
      MDMA-assisted therapy compared to placebo with therapy?

      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 psychotherapy sessions and non-drug integrative sessions.

      The study will test whether MDMA-assisted therapy can be safely given to participants.
      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have current PTSD (within the past 6 months) in response to crime victimization,
             including childhood sexual or physical abuse, or meet criteria for PTSD in response to
             combat;

          -  Have a CAPS score showing moderate to severe PTSD symptoms;

          -  They must either:

               1. Have had at least one unsuccessful attempt at treatment for PTSD with a SSRI and
                  psychotherapy;

               2. Be a veteran with PTSD symptoms that have endured for no less than one year but
                  no more than five years

          -  Be at least 18 years old;

          -  Must be generally healthy;

          -  Willing to remain overnight at the study site;

          -  Agree to have transportation home the morning 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 reading English;

        Exclusion Criteria:

          -  Are pregnant or nursing, or are able to bear children and are not practicing an
             effective means of birth control;

          -  Weigh less than 50 kg or more than 105 kg;

          -  Are unable to give adequate informed consent;

          -  Have a history of certain excluded medical disorders.