Clinical TrialMDMAMDMAPlaceboTerminated

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

Double-blind, ascending-dose, randomised, placebo-controlled pilot of low-dose MDMA-assisted psychotherapy for chronic PTSD (J Psychoactive Drugs 2008 Sep; Bouso JC, Doblin R, Farré M, Alcázar MA, Gómez-Jarabo G; Madrid, Spain; PMID 19004414; DOI 10.1080/02791072.2008.10400637; MAPS-supported). n=6 women with chronic PTSD secondary to sexual assault; recruited Madrid 2000–2002; aged 29–49, weight 50–61.3 kg, no prior MDMA experience; failed ≥1 standard treatment; free of psychotropic medication ≥1 month; negative pregnancy test at administration. Ascending-dose MDMA (low doses, detail in paper) vs placebo; double-blind design. Study terminated early due to regulatory intervention by Spanish Health Ministry. No CT.gov registration (pre-modern registration era; Spanish regulatory action in ~2002). CT.gov: 0 hits.

Target Enrollment
6 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

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).

Primary Results(1 publication)

Participants

N = 6Mean age: 33–38 across armsC. et al. 2008 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
MDMA 50mgexperimental31(33.3%)0(0.0%)——
MDMA 75mgexperimental11(100.0%)0(0.0%)——
Placeboplacebo20(0.0%)0(0.0%)——

* Only Subject 1 (MDMA 50mg) reported very mild side effects at the 24-hour assessment. Subjects 3 and 4 did not report side effects.

* Subject 5 (MDMA 75mg) reported very mild side effects at the 24-hour assessment.

* No placebo subjects reported side effects.

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

Related Publications

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

Published
Authors
Bouso, J. C., Doblin, R., Farré, M., Gómez-Jarabo, G.

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