MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders

Part of paid clinical trials in Boulder, Colorado.

Sponsor
Nautilus Sanctuary
Study ID
NCT05455996
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MDMA — DRUG
    MDMA-assisted therapy

Study Details

The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Frontline Health Care Workers and First Responders suffering from symptoms of Post-Traumatic Stress.

Key Dates

Start date
Oct 31, 2026
Status verified
Nov 2025
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: MDMA-assisted therapy
    Participants will receive 3-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions)

Primary Outcome Measure

Change from Baseline on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment Termination [ Time Frame: Up to 17 weeks post-enrollment (Baseline) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
MemoruBoulderColorado80302
Marcela Ot'alora, MA, LPC
[email protected]
303.818.1419
Marcela Ot'alora, MA, LPC (PRINCIPAL_INVESTIGATOR)
InnerMost, PBCNew YorkNew York10010
Liana Eisler Study Coordinator, B.A.
[email protected]
917-336-2608
Casey Paleos, MD (PRINCIPAL_INVESTIGATOR)
The Pearl InstituteWaynesvilleNorth Carolina28786
Raymond C Turpin, PsyD
[email protected]
(828) 378-1527
Joel Chisholm, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boulder, CO

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Memoru· Boulder, COInnerMost, PBC· New York, NYThe Pearl Institute· Waynesville, NC

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