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RecruitingPhase 1 / Phase 2

Tolerability of MDMA in Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well adults ages 18–60 with stable schizophrenia can tolerate MDMA. Participants receive increasing doses while doctors check for symptoms such as hearing or seeing things that are not there. The results will help guide future studies of MDMA for people with schizophrenia who have trouble wanting to spend time with others.

Impaired social motivation, or "asociality," is a negative symptom of schizophrenia (SCZ) and a cause of significant functional impairment in the illness. Whereas many symptoms of schizophrenia can be treated with antipsychotic medications, deficits in social motivation persist, leading to significant social disability in patients. There is currently no effective treatment for this symptom of the illness. One promising and unexplored avenue to enhance social motivation in schizophrenia is ± 3,4-methylenedioxymethamphetamine (MDMA). MDMA is a psychostimulant that shares some pharmacological properties with amphetamines, but in addition, has pronounced pro-social effects, increasing the motivation to engage socially. In healthy volunteers, it produces feelings of empathy and closeness with others and increases attention to positive social cues, perhaps partly through its effects on the social bonding hormone, oxytocin. MDMA has shown promise in other psychiatric conditions such as PTSD. Thus, MDMA could offer a unique therapeutic benefit in patients with SCZ who suffer from impaired social motivation. The investigators plan to take the first step in testing MDMA as a treatment for these social deficits by testing the tolerability of the drug in patients with SCZ. This will be an open-label, ascending-dose, within-subject trial in which participants will receive 40mg, 80mg, or 120mg of MDMA. The doses will be administered in ascending order, but doses will be stopped if subjects experience moderate or greater psychotic symptoms at 24 hours. This trial will assess the tolerability of the drug in this population and guide in the selection of a maximum well-tolerated dose for future studies. The primary tolerability measure will be clinician-rated psychotic symptoms (disorganized speech, delusions, hallucinations) collected at 24 hours after MDMA administration. The results of this project will lay the foundation for further investigations of MDMA and other psychoactive compounds as a treatment for debilitating and difficult-to-treat social deficits in schizophrenia. Future studies will examine interactions between the effects of psychoactive compounds and nonpharmacologic psychosocial interventions targeting social symptoms.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18–60 years old.
  • Can understand spoken English well enough to follow the study tests.
  • Have schizophrenia confirmed through a clinical interview.
  • Have had no hospital stays or medication changes in the past 6 months.

Who can't join

  • Have a history of aggressive or suicidal behavior while having trouble knowing what is real.
  • Have a history of an IQ below 70 or a disability that began during development.
  • Have a major brain or nerve disease, such as epilepsy; a heart condition, such as an irregular heartbeat; or a certain abnormal heart rhythm test result called prolonged QTc.
  • Have had a serious head injury that caused more than 1 hour of unconsciousness, lasting thinking problems, or a need for treatment to rebuild thinking skills.
  • Have had an alcohol or drug use disorder in the past 6 months, have a positive urine drug test, or appear under the influence on the test day.
  • Have used sedatives or benzodiazepines, medicines that calm or cause sleepiness, within 24 hours of testing; or currently take SSRI or SNRI antidepressants.
  • Are pregnant or think you might be pregnant.
  • Have a history of neuroleptic malignant syndrome (NMS) or serotonin syndrome, serious reactions to certain medicines.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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: * 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 sites (1)

CA