Clinical TrialSchizophreniaMDMAMDMAMDMARecruiting

Tolerability of MDMA in Schizophrenia (TMS)

Open-label, ascending-dose, within-subject tolerability study (n=20) of MDMA (40, 80, 120 mg) in clinically stable patients with schizophrenia to assess psychotic symptom response at 24 hours.

Target Enrollment
20 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

Impaired social motivation (asociality) is a disabling negative symptom of schizophrenia with no effective pharmacologic treatment; MDMA has pro-social effects in healthy volunteers and other psychiatric disorders and may target social motivation deficits.

This open-label, ascending-dose, single-group trial will administer oral MDMA in ascending order (40 mg, 80 mg, 120 mg) within subjects, stopping escalation if participants exhibit moderate or greater psychotic symptoms at 24 hours.

Primary tolerability outcome is clinician-rated psychotic symptoms at 24 hours; findings will inform selection of a maximum well-tolerated dose for future efficacy studies targeting social deficits.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

MDMA ascending

experimental

Within-subject ascending single doses of MDMA (40 → 80 → 120 mg) assessing tolerability.

Interventions

  • MDMA40 mg
    via Oral• single dose

    First session 40 mg, ascending if tolerated; stop escalation if moderate+ psychotic symptoms at 24 h.

  • MDMA80 mg
    via Oral• single dose

    Second session 80 mg in ascending schedule.

  • MDMA120 mg
    via Oral• single dose

    Third session 120 mg if prior doses tolerated; primary tolerability assessed at 24 h.

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Ages 18-60
  • able to understand spoken English sufficiently to comprehend testing procedures
  • DSM-5 diagnosis of schizophrenia, based on clinical interview
  • clinical stability (i.e., no inpatient hospitalizations for six months prior to enrollment, no changes in medication in for 6 months prior to enrollment)

Exclusion Criteria

  • Exclusion Criteria:
  • no history of aggressive or suicidal behavior while psychotic
  • no history of IQ less than 70 or developmental disability, based on medical history
  • no clinically significant neurological disease (e.g., epilepsy), or cardiovascular condition (e.g. cardiac arrhythmia) based on medical history
  • no history of serious head injury (i.e., loss of consciousness longer than 1 hour, neuropsychological sequelae, cognitive rehabilitation treatment after head injury) based on medical history
  • no substance or alcohol use disorder in the past six months
  • no sedatives or benzodiazepines within 24 hours of testing
  • no positive urine toxicology screen or visible intoxication on the day of assessment
  • no women who are pregnant or think that they might be pregnant, based on self-report and urine test
  • not currently taking SSRIs or SNRIs
  • no history of NMS or serotonin syndrome
  • No prolongation of the QTc interval on EKG

Study Details

  • Status
    Recruiting
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2023-03-15
    End: 2025-03-15
  • Compounds
    MDMAMDMAMDMA
  • Topic
    Schizophrenia

Locations

UCLA — Los Angeles, California, United States

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