Health TrialsbyHealthPanel

MDMA Therapy in Veterans With PTSD

ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunstone Medical

About this trial

A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veterans who are at least 18 years old

Are able to swallow pills

Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.

Proficient in speaking and reading English.

Disqualifiers

Condition impairing oral intake or digestive absorption.

Unable to give adequate informed consent.

Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months

Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)

Trial design

Design model

Parallel

Treatments tested in this trial

  • MDMA

    Drug

    MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: IndividualExperimental treatment 1 intervention
Group B: GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability

To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit.

Time frame
15 months
2

C-SSRS

Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale \[C-SSRS\]) score at all visits from Baseline to EOS Visit.

Time frame
15 months

Secondary outcomes

1

Efficacy of Therapy

To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Clinician Administered PTSD Scale. (CAPS-5)

Time frame
15 months
2

Effect of Therapy

To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Sheehan Disability Scale. (SDS)

Time frame
15 months
3

Efficacy of Therapy

To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the PTSD Checklist for DSM-5.(PCL-5)

Time frame
15 months
4

Efficacy of Therapy

To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the State-Trait Anxiety Inventory. (STAI)

Time frame
15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunstone Medical

Lead sponsor

Source ClinicalTrials.gov
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