Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Midomafetamine; Therapy
Intervention description: 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later; Non-directive therapy
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MDMA; PTSD; therapy

Summary:

      This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA
      for people who took part in a study of MDMA-assisted therapy in people with posttraumatic
      stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after
      the first MDMA sessions. The single session will be performed by the same pair of therapists
      who performed the sessions in the first study. People will have a preparatory session, the
      MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms
      of depression will be measured at the start of this study and two and 12 months after the
      session.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be diagnosed with chronic PTSD;

          -  Have a CAPS score showing moderate to severe PTSD symptoms;

          -  Have participated in MP-1;

          -  Are at least 18 years old;

          -  Must be generally healthy;

          -  Must sign a medical release for the investigators to communicate directly with their
             therapist and doctors;

          -  Are willing to refrain from taking any psychiatric medications during the study
             period;

          -  Willing to follow restrictions and guidelines concerning consumption of food,
             beverages, and nicotine the night before and just prior to each experimental session;

          -  Willing to remain overnight at the study site;

          -  Agree to have transportation other than driving themselves home or to where they are
             staying after the integrative session on the day after the MDMA session;

          -  Are willing to be contacted via telephone for all necessary telephone contacts;

          -  Must have a negative pregnancy test if able to bear children, and agree to use an
             effective form of birth control;

          -  must provide a contact in the event of a participant becoming suicidal;

          -  Are proficient in speaking and reading English;

          -  agree to have all clinic visit sessions recorded to audio and video

          -  Agree not to participate in any other interventional clinical trials during the
             duration of this study.

        Exclusion Criteria:

          -  Are pregnant or nursing, or if a woman who can have children, those who are not
             practicing an effective means of birth control;

          -  Weigh less than 48 kg;

          -  Are abusing illegal drugs;

          -  Are unable to give adequate informed consent;

          -  Upon review of past and current drugs/medication must not be on or have taken a
             medication that is exclusionary;

          -  Upon review of medical or psychiatric history must not have any current or past
             diagnosis that would be considered a risk to participation in the study.