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

Post Traumatic Stress Disorder Clinical Trial

Official title:
A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD

Clinical Trial Summary

This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05790239
Study type Interventional
Source VA Greater Los Angeles Healthcare System
Contact Stephanie L Taylor, PhD
Phone 213-505-1140
Email Stephanie.Taylor8@va.gov
Status Not yet recruiting
Phase Phase 2
Start date October 2023
Completion date March 2026
View Details
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