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NCT06565494 · ClinicalTrials.gov registry record · Early Phase 1

MDMA-Assisted Therapy for Pathological Narcissism

A Early Phase 1 study of Narcissism, sponsored by University of Washington.

Active
Registry status
Early Phase 1
Development phase
12
Enrollment target
1
Study location

NCT06565494: Active Early Phase 1 study of Narcissism, sponsored by University of Washington.

NCT06565494 is a Early Phase 1 study of Narcissism that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06565494, a Early Phase 1 study of Narcissism, is active but no longer recruiting, sponsored by University of Washington.

ACTIVE NOT RECRUITING
Registry status
Early Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine (MDMA) - assisted therapy (AT) for participants diagnosed with pathological narcissism. As all participants will be allocated to a single group assignment, there will be no blinding, randomization, or comparator treatment. Participants will have a screening visit, a preparation period of 3 visits, a treatment period receiving MDMA-AT at 3 monthly visits, a 6 month follow up period coming in at one week, one month, three months and six months after last treatment visit.

Primary Outcome

Assess changes in diagnostic features of pathological narcissism per self-report. This measure has 52 items each rated on a 6-point Likert scale with higher scores indicating higher severity.

Conditions Studied

Interventions

  • DRUG midomafetamine (MDMA)-Assisted Therapy

Study Locations (1)

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2024-08-27
Est. Completion 2027-01-31
Phase Early Phase 1
University of Washington

1,048 total trials

What the registry record for NCT06565494 still lists

NCT06565494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).

The record links to 1 condition, with Narcissism appearing as the primary indexed condition, and to 1 intervention - of which midomafetamine (MDMA)-Assisted Therapy is the first listed.

NCT06565494 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT06565494 about?

NCT06565494 is a clinical study titled "MDMA-Assisted Therapy for Pathological Narcissism". This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine (MDMA) - assisted therapy (AT) for participants diagnosed with pathological narcissism. As all participants will be allocated to a single group assignment, there will be no blinding, randomization, or...

What is the current status of trial NCT06565494?

This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2024-08-27. Estimated completion is 2027-01-31.

What conditions does trial NCT06565494 study?

This clinical trial studies the following conditions: Narcissism.

What interventions are being tested in trial NCT06565494?

The interventions under investigation include: midomafetamine (MDMA)-Assisted Therapy (DRUG).

Who is sponsoring clinical trial NCT06565494?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06565494 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06565494's enrollment target sits among peer trials

12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06565494, the US trial registry maintained by the National Library of Medicine. NCT06565494 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.