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CompletedNCT04264026

Phase 2 Study of MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD

This study is completed in the United States. It is testing MDMA-Assisted Psychotherapy for PTSD.

PTSD, Combat Stress DisordersDrugFrom 18 Years to 55 Years
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In plain English

Key information made simple

This summary needs review. Please check the official study record and contact the research team for details.

What to expect

Your next step

The official record does not clearly describe the visit format, so the practical details are best checked directly in the source. Participation appears to involve study activities and follow-up chosen by the research team. The main fit and exclusions are best confirmed in the eligibility section of the official record. The phase details are not clearly stated here.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: July 29, 2021
Recruitment status
Completed
Estimated enrollment
5
Sponsor
VA Loma Linda Health Care System
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
PHASE2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States
Age range
From 18 Years to 55 Years
Official registry ID
NCT04264026
Official title
Open-label Phase 2 Study of MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD
Official source
Official registry link

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Study ID: NCT04264026. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular follow-up, often through questionnaires or interviews.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

Based on the public registry summary, this study is trying to understand: This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with. The study team can confirm the exact objective and what it means for you.

Does this study involve a medication?

This appears to be a medication / drug study involving 3,4-methylenedioxymethamphetamine. The listed phase is PHASE2. Ask the study team what that means in practice for safety, monitoring, and criteria.

Do I need to want to stop or reduce tobacco use to participate?

The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

Will I need to change, stop, or stabilize my current treatment?

The public registry appears to mention rules about current treatment, stability, stopping treatment, or dose changes. Do not change your treatment for a study without medical guidance. Ask the study team and your clinician what is required, what is not allowed, and how safety is monitored.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by VA Loma Linda Health Care System, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is completed. It may still be useful for understanding the research, but you are unlikely to be able to join. The registry lists an estimated enrollment of 5 participants.

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