Tolerability of MDMA in Schizophrenia

Part of paid clinical trials in Los Angeles, California.

Sponsor
Anya Bershad, MD, PhD
Study ID
NCT05770375
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • MDMA 40mg — DRUG
    MDMA 40mg
  • MDMA 80mg — DRUG
    MDMA 80mg
  • MDMA 120mg — DRUG
    MDMA 120mg

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
May 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MDMA
    Each subject will receive 3 doses of MDMA in ascending order: 40mg, 80mg, 120mg.

Primary Outcome Measure

Positive and Negative Syndrome Scale for Schizophrenia (PANSS): Disorganized speech. [ Time Frame: 24 hours after each drug session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90025
Gerard De Vera
[email protected]
310-794-5577

Find similar trials in Los Angeles, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
UCLA· Los Angeles, CA

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