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MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
NCT05790239 · VA Greater Los Angeles Healthcare System
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
Eligibility criteria
Inclusion Criteria:
* At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.
* Fluent in speaking and reading the predominantly used or recognized language of the study site (English).
* Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.
* Able to swallow pills.
* Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.
* Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.
* Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.
* May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.
* May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
* Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI must be within 18 to 32 kg/m2 (inclusive).
* A person able to be pregnant (PABP) must use a highly effective contraceptive method.
Exclusion Criteria:
* Are not able to give adequate informed consent.
* Have evidence or history of significant medical or psychiatric disorders.
* Are abusing illegal drugs.
* Unable or unwilling to safely taper off prohibited psychiatric medication.
* Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-01
Estimated completion: 2026-03
Last updated: 2025-03-28
Interventions
Drug: 3,4-methylenedioxymethamphetamineDrug: d-amphetamineBehavioral: Therapy
Primary outcomes
- • Compare changes in PTSD symptom severity in the MDMA vs active control group. (Visit 17 (approximately 14 weeks after enrollment))
Sponsor
Stephen Robert Marder · fed
Contacts & investigators
ContactStephanie L Taylor, PhD · contact · Stephanie.Taylor8@va.gov · 213-505-1140
ContactStephen Marder, MD · contact · Stephen.Marder@va.gov
InvestigatorStephen Marder, MD · principal_investigator, VA Greater Los Angeles Healthcare System
InvestigatorStephanie L Taylor, PhD · principal_investigator, VA Greater Los Angeles Healthcare System
All locations (2)
VA Greater Los Angeles Healthcare System, Westwood campusNot Yet Recruiting
Los Angeles, California, United States
West Los Angeles Veteran AffairsRecruiting
Los Angeles, California, United States