Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: 3,4-methylenedioxymethamphetamine (125 mg); 3,4-methyelendioxymethamphetamine (25 mg); Therapy
Intervention description: Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.; Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.; Non-directive therapy performed 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: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTSD, MDMA, psychotherapy, Switzerland

Summary:

      This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older
      diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment.
      This objective of this study is to determine whether three eight-hour long sessions of
      MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered
      to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with
      psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD
      symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or
      assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three
      experimental sessions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with posttraumatic stress disorder (PTSD).

          -  PTSD still remains after one or more prior treatment, with treatment including
             psychotherapy (talk therapy) or drug therapy

          -  May meet criteria for a mood disorder

          -  Must be at least 18 years old

          -  Must be able to stop taking psychiatric medication during the course of the study,
             from the start of the study to the follow-up two months after experimental session 3.

          -  Must agree to follow all rules and instructions relating to the experimental session,
             including restrictions on food and substance (alcohol and drug) consumption.

          -  Must be willing to stay overnight at the researcher's office after each experimental
             session until the non-drug session occurring the next morning.

          -  Must be willing to be contacted by one of the researchers on a daily basis for a week
             after each experimental session.

          -  Female participants of childbearing potential must have a negative pregnancy test and
             must agree to use an effective form of birth control.

          -  Participants must have sufficient proficiency in speaking the German language to
             participate in MDMA-assisted psychotherapy. Participants must be able to read
             documents in German.

        Exclusion Criteria:

          -  Cannot have history of or current primary psychotic disorder or bipolar affective
             disorder-1.

          -  Dissociative identity disorder, or an eating disorder with active purging or
             borderline personality disorder.

          -  Evidence or history of significant hematological, endocrine, cerebrovascular,
             cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or
             neurological disease, including seizure disorder. (People with hypothyroidism who are
             on adequate and stable thyroid replacement will not be excluded).

          -  Uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or
             without abnormal liver enzymes), or history of hyponatremia or hyperthermia.

          -  Being pregnant or lactating (nursing), or not practicing an effective method of birth
             control.

          -  Weight of less than 50 or more than 105 kg.

          -  Patients reporting prior use of "Ecstasy" more than 5 times or at any time within the
             previous 6 months.

          -  People who would present a serious suicide risk or who are likely to require
             hospitalization during the course of the study.

          -  People who need ongoing concomitant therapy with a psychotropic drug.

          -  Meeting DSM-IV criteria for substance abuse or dependence for any substance save
             caffeine or nicotine in the past 60 days.

          -  People who cannot give adequate consent.