PROPOSED STUDY DESIGNS

1
Israel Conference, Tel Aviv, 24-3-05 MDMA/PTSD
research in Spain. Preliminary data and future
perspectives José Carlos Bouso Saiz
(jcbouso_at_gmail.com) Cátedra de la Fundación
Cultural Fórum Filatélico de Psicobiología y
Discapacidad Departamento de Psicología
Biológica y de la Salud Facultad de
Psicología Universidad Autónoma de Madrid 28049
Madrid Spain
2
PROPOSED STUDY DESIGNS

• DOSE-FINDING PILOT STUDY
• Group 1 (5 subjects) MDMA 50 mg
• (3 subjects)
• placebo (1 subject)
• Group 2 (7 subjects) MDMA 75 mg
• (5 subjects)
• placebo (2 subjects)
• Group 3 (7 subjects) 100 mg de MDMA
• (5 subjects)
• placebo (2 subjects)
• Group 4 (7 subjects) 125 mg de MDMA
• (5 subjects)
• placebo (2 subjects)
• Group 5 (5 subjects) 150 mg de MDMA
• (3 subjects)

• EFFICACY PILOT STUDY
• - Group 1 (15 subjects) MDMA (the most efficacy
  dose obtained from the dose-finding pilot study)
• - Group 2 (15 subjects) placebo

3
Psychometric measures

• A Strutured Clinical Interview based on the
  DSM-IV (the SCID).
• The Scale of Severity of Symptoms of PTSD.
• A Semi-Structured Interview regarding sexual
  aggression.
• STAI/S. The STAI in its State version.
• BDI. The Beck Depression Inventory.
• HRS. The Hamilton Rating Scale for depression.
• MFS-III. The Modified Fear Scale (assess specific
  fears related with a sexual assault).
• A Maladjustment Scale.
• SE/R. The Rosenger Self-Esteem Scale.
• HRS-S. The Hallucinogen Rating Scale, HRS.
• The UKU side-effects rating scale.
• HAq. The Helping Alliance questionnaire.

4
OBJECTIVES

• To assess the security of different doses of MDMA
  in chronic PTSD population
• To obtain preliminary data about the efficacy of
  MDMA in the treatment of PTSD
• To familarize the therapeutic team with the
  treatment with MDMA and to refine the therapeutic
  approach
• To assess how the proposed rating scales work in
  order to refine them in future studies

5
TREATMENT PLAN