Israel Conference, Tel Aviv, 24-3-05

MDMA/PTSD research in Spain. Preliminary data and future perspectives

José Carlos Bouso Saiz (jcbouso@gmail.com)

Cátedra de la “Fundación Cultural Fórum Filatélico de Psicobiología y Discapacidad”

Departamento de Psicología Biológica y de la SaludFacultad de Psicología

Universidad Autónoma de Madrid28049 Madrid

Spain

PROPOSED STUDY DESIGNSPROPOSED STUDY DESIGNSDOSE-FINDING PILOT STUDYDOSE-FINDING PILOT STUDY

Group 1 (5 subjects): Group 1 (5 subjects): MDMA 50 mg MDMA 50 mg (3 subjects)(3 subjects)placebo (1 subject)placebo (1 subject)

Group 2 (7 subjects): Group 2 (7 subjects): MDMA 75 mg MDMA 75 mg (5 subjects)(5 subjects)placebo (2 subjects)placebo (2 subjects)

Group 3 (7 subjects): 100 mg de MDMA Group 3 (7 subjects): 100 mg de MDMA (5 subjects)(5 subjects)placebo (2 subjects)placebo (2 subjects)

Group 4 (7 subjects): Group 4 (7 subjects): 125 mg de MDMA 125 mg de MDMA (5 subjects)(5 subjects)placebo (2 subjects)placebo (2 subjects)

Group 5 (5 subjects): Group 5 (5 subjects): 150 mg de MDMA 150 mg de MDMA (3 subjects)(3 subjects)placebo (1 placebo (1 subjectsubject))

TOTAL SUBJECTS: 29 (MDMA: 21; placebo: 8)TOTAL SUBJECTS: 29 (MDMA: 21; placebo: 8)

EFFICACY PILOT STUDYEFFICACY PILOT STUDY

- Group 1 (15 subjects): - Group 1 (15 subjects): MDMA (the most efficacy MDMA (the most efficacy dose obtained from the dose obtained from the dose-finding pilot study)dose-finding pilot study)

- Group 2 (15 subjects): - Group 2 (15 subjects): placeboplacebo

Psychometric measuresPsychometric measures

A Strutured Clinical Interview based on the DSM-IV (the A Strutured Clinical Interview based on the DSM-IV (the SCID).SCID).

The Scale of Severity of Symptoms of PTSD.The Scale of Severity of Symptoms of PTSD. A Semi-Structured Interview regarding sexual aggression.A Semi-Structured Interview regarding sexual aggression. STAI/S. The STAI in its State version.STAI/S. The STAI in its State version. BDI. The Beck Depression Inventory.BDI. The Beck Depression Inventory. HRS. The Hamilton Rating Scale for depression.HRS. The Hamilton Rating Scale for depression. MFS-III. The Modified Fear Scale (assess specific fears MFS-III. The Modified Fear Scale (assess specific fears

related with a sexual assault).related with a sexual assault). A A Maladjustment Scale.Maladjustment Scale. SE/R. The Rosenger Self-Esteem Scale. SE/R. The Rosenger Self-Esteem Scale. HRS-S. The Hallucinogen Rating Scale, HRS.HRS-S. The Hallucinogen Rating Scale, HRS. The UKU side-effects rating scale.The UKU side-effects rating scale. HAq. The Helping Alliance questionnaire.HAq. The Helping Alliance questionnaire.

OBJECTIVESOBJECTIVES

To assess the security of different doses of To assess the security of different doses of MDMA in chronic PTSD populationMDMA in chronic PTSD population

To obtain preliminary data about the efficacy To obtain preliminary data about the efficacy of MDMA in the treatment of PTSDof MDMA in the treatment of PTSD

To familarize the therapeutic team with the To familarize the therapeutic team with the treatment with MDMA and to refine the treatment with MDMA and to refine the therapeutic approachtherapeutic approach

To assess how the proposed rating scales To assess how the proposed rating scales work in order to refine them in future studieswork in order to refine them in future studies

TREATMENT PLAN TREATMENT PLAN SCID, ECG and medical

analysis

Psychometric scales

Experimentalsession:

MDMA or placebo

Psychotherapy session

Day 1 X

Day 2 (7 days after day 1)

X (except UKU and

HRS-S)

X

Day 3 (7 days after day 2)

X (except UKU)

X

Day 4 (7 days afetr day 3)

X (only HAq)

X

Day 5 (7 days after day 4)

X (only HAq)

X X

Day 6 (7 days after day 4)

X (only UKU; HRS-

S; HAq)

X

Day 7 (7 days after day 5)

X (only UKU and

HAq)

Day 8 (7 days after day 1)

X (except

semistructuredinterview, UKU,

and HRS-S)

X