Clinical TrialPTSDMDMAMDMAPlaceboTerminated

MDMA-Assisted Psychotherapy Low-Dose Pilot for Chronic PTSD: Double-Blind RCT (Bouso / Doblin / Farré, Madrid Spain 2000–2002)

This unregistered trial (n=6) was a double-blind, placebo-controlled pilot of low-dose MDMA-assisted psychotherapy for chronic PTSD in women, which was terminated early following regulatory intervention by the Spanish Health Ministry.

Ask Blossom about this trial
Target Enrollment
6 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.

The study investigated the safety and preliminary efficacy of low-dose MDMA (50–75 mg) administered within a psychotherapeutic setting. The participants were women with chronic post-traumatic stress disorder (PTSD) resulting from sexual assault who had previously failed to respond to standard treatments.

Although the trial was originally designed to include 29 subjects, it was terminated early due to regulatory intervention by the Spanish Health Ministry. Preliminary results from the six participants treated indicated that the low doses of MDMA were both psychologically and physiologically safe.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

maps

Study Arms & Interventions

MDMA 50mg

experimental

Single dose of 50 mg MDMA administered in a psychotherapeutic setting.

Interventions

  • MDMA50 mg
    via Oral• single dose• 1 doses total

    Administered in a psychotherapeutic setting with 6 psychotherapy sessions (3 before, 3 after).

MDMA 75mg

experimental

Single dose of 75 mg MDMA administered in a psychotherapeutic setting.

Interventions

  • MDMA75 mg
    via Oral• single dose• 1 doses total

    Administered in a psychotherapeutic setting with 6 psychotherapy sessions (3 before, 3 after).

Placebo

placebo

Placebo dose administered in a psychotherapeutic setting.

Interventions

  • Placebo
    via oral• single dose• 1 doses total

    Administered in a psychotherapeutic setting with 6 psychotherapy sessions (3 before, 3 after).

Study Details

  • Status
    Terminated
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment6 participants
  • Timeline
    Start: 2000-01-01
    End: 2002-12-31
  • Compounds
    MDMAMDMAPlacebo
  • Topic
    PTSD

Study Team

Sponsors & Collaborators

Locations

Spain

Related Publications

Open AccessindividualPrimary

MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder

This small double-blind placebo-controlled study (n=6) studied the safety (psychological & physiological) of a low dose of MDMA (50-75mg) in women with chronic PTSD and found no adverse effects.

Published
Journal
Journal of Psychoactive Drugs
Authors
Bouso, J. C., Doblin, R., Farré, M., Gómez-Jarabo, G.