MDMA-assisted Massed Prolonged Exposure for PTSD

Part of paid clinical trials in San Diego, California.

Sponsor
Healing Breakthrough
Study ID
NCT06117306
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • 3,4 Methylenedioxymethamphetamine — DRUG
    1 MDMA session
  • Prolonged Exposure — BEHAVIORAL
    12 90-minute PE sessions; initial two sessions both occurring during the first treatment visit, third and fourth sessions occurring during the MDMA session, and the remaining sessions occurring daily or every other day

Study Details

The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive different doses of MDMA.

Key Dates

Start date
Oct 25, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose A (exact dose not disclosed)
    Non-medicine sessions of PE + One Medicine Session with 3,4-methylenedioxymethamphetamine (MDMA) PE Non-medicine sessions: 12 sessions MDMA Medicine session: Dose: exact dose not disclosed
  • Experimental: Dose B (exact dose not disclosed)
    Non-medicine sessions of PE + One Medicine Session with 3,4-methylenedioxymethamphetamine (MDMA) PE Non-medicine sessions: 12 sessions MDMA Medicine session: Dose: exact dose not disclosed

Primary Outcome Measure

Clinician-rated PTSD symptoms [ Time Frame: Baseline - 4-months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161
Leslie Morland
[email protected]
858-226-5765
Leslie Morland, PsyD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
VA San Diego Healthcare System, San Diego, CA· San Diego, CA

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