This open-label trial (n=20) aims to investigate the tolerability of ± 3,4-methylenedioxymethamphetamine (MDMA) in patients with schizophrenia. Impaired social motivation is a negative symptom of schizophrenia that has no effective treatment, and MDMA has shown promise in increasing social motivation and bonding in healthy individuals and other psychiatric conditions such as PTSD.
The trial will administer ascending doses of 40mg, 80mg, and 120mg of MDMA to participants and assess the tolerability of the drug in this population. The primary tolerability measure will be clinician-rated psychotic symptoms, including disorganized speech, delusions, and hallucinations, collected 24 hours after MDMA administration. The results of this trial will guide the selection of a maximum well-tolerated dose for future studies. MDMA may offer a unique therapeutic benefit in patients with schizophrenia who suffer from impaired social motivation.
Trial Details
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Sponsors & Collaborators
University of California San DiegoThe Psychedelics and Health Research Initiative (PHRI) at UC San Diego conducts novel basic and clinical research on the use of psychedelics.