Clinical TrialMDMACompleted

MDMA-Assisted Therapy Open Clinical Series: Subjective Reports (Greer & Tolbert, San Francisco / Santa Fe 1980–1983)

Open, uncontrolled clinical observational series of MDMA-assisted sessions with self-referred participants (J Psychoactive Drugs 1986 Oct-Dec; Greer G, Tolbert R; San Francisco and Santa Fe NM; PMID 2880946; DOI 10.1080/02791072.1986.10472364). n=29 participants; sessions conducted 1980–1983. MDMA synthesised by Alexander Shulgin, identity confirmed by infrared spectrophotometry. Participants self-referred or referred by psychotherapists or friends specifically for MDMA sessions; none from treating psychiatrist's private practice. 5 subjects completed screening retrospectively. Analysis focused on subjective reports and self-rated effects of MDMA in a therapeutic context. No control arm; no registration (pre-registration era, 1986). CT.gov: 0 hits.

Target Enrollment
29 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

MDMA

experimental

Oral administration of MDMA, with some subjects receiving a second dose to prolong the session.

Interventions

  • MDMA25 mg
    via oral• single dose• 1 doses total

    Initial oral dose ranged from 25-150 mg. Some subjects received a second dose of 50 mg or 75 mg to prolong the session.

Primary Results(1 publication)

Participants

N = 29R. et al. 1986 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
MDMAexperimental2929(100.0%)—0(0.0%)—

* All 29 subjects reported some undesirable experience during or after their sessions. No side effects were serious. The longest any symptom persisted was one week, except for two subjects. Specific undesirable experiences reported include: jaw tension/shaking (22 subjects), fatigue (23 subjects), insomnia (11 subjects), muscle aches/tightness (8 subjects), loss of appetite (28 subjects), nausea (7 subjects), difficulty walking (3 subjects), feeling cold (2 subjects), sweating (2 subjects). One subject (No. 19) experienced post-session psychological difficulties that were disabling or of more than a few days duration.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment29 participants
  • Timeline
    Start: 1980-01-01
    End: 1983-12-31
  • Compound
    MDMA

Related Publications

Subjective reports of the effects of MDMA in a clinical setting

Published
Authors
Greer, G. R.

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