MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

This randomized, double-blind, single-site phase II trial (n=40) will investigate MDMA-assisted therapy’s safety and preliminary efficacy compared with low-dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in veterans with at least moderate PTSD severity. The study will consist of a screening period, preparatory period, treatment period involving three experimental sessions and three integrative sessions, followed by a follow-up period and study termination visit, including CAPS-5 assessments.

Topic PTSD
Compound MDMA
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 October 2023
End date 01 March 2026
Chance of happening 100%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 40
Sex All
Age 18- 99
Therapy Yes

Trial Details

This randomized, double-blind, single-site phase II 2-arm study will compare MDMA-assisted therapy with low dose d-amphetamine-assisted therapy to treat PTSD symptoms in veteran participants aged 18 years and older with PTSD of at least moderate severity, as measured by the change in CAPS-5 total severity score. The study will be conducted in up to N=40 participants from the Greater Los Angeles VA randomized with a 1:1 allocation to Group 1: MDMA-assisted therapy or Group 2: low dose d-amphetamine assisted therapy. For each participant, the study will consist of: Screening Period: phone screen, informed consent, eligibility assessment, Screening CAPS-5, and Initial Enrollment of eligible participants. Preparatory Period: medication tapering, three Preparatory Sessions, baseline assessments (including Baseline CAPS-5), leading to Enrollment Confirmation. Treatment Period: three Experimental Sessions, and three Integrative Sessions following each Experimental Session including CAPS-5 assessments. Follow-up Period and Study Termination: Primary Outcome CAPS-5 assessment and Study Termination visit.

NCT Number NCT05790239

Sponsors & Collaborators

US Department of Veteran Affairs
The US Department of Veteran Affairs is playing an important role in the psychedelic renaissance by exploring and monitoring advancements in psychedelic therapies and the viability of these therapies for veterans with PTSD.

Data attribution

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