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Treatments

MDMA-Assisted Therapy

Structured therapeutic support for complex PTSD and trauma.

In clinical trials

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Legal status: MDMA is a Schedule I substance and is not FDA-approved as a treatment. Navii refers only to licensed clinicians offering preparation and integration therapy or active clinical-trial pathways such as those listed on clinicaltrials.gov. This page is informational and not medical advice.

MDMA-assisted therapy is a structured therapeutic approach combining MDMA with intensive psychotherapy sessions to process trauma, particularly PTSD. Phase 3 trials run by MAPS and its sponsor Lykos Therapeutics reported response rates significantly exceeding conventional PTSD treatments.

MDMA-assisted therapy is not currently FDA-approved. In August 2024, the FDA declined Lykos Therapeutics' application and asked for additional Phase 3 research, which is underway. In the meantime, many trauma therapists offer MDMA-informed preparation and integration support as a legal complement to clinical-trial participation or to experiences obtained in legal jurisdictions. Navii connects patients with clinicians trained in these approaches who work within current legal frameworks.

Who it's for

Complex PTSD, trauma survivors, veterans, first responders, and individuals for whom conventional trauma therapy has produced limited results.

Common questions

Is MDMA-assisted therapy legal?+

MDMA is not FDA-approved as a treatment. The FDA declined Lykos Therapeutics' 2024 application and additional Phase 3 trials are underway. Trained clinicians can legally provide preparation and integration therapy and, where available, clinical-trial pathways.

Who is MDMA-assisted therapy designed for?+

It's primarily studied for PTSD and complex trauma, particularly cases that haven't responded to conventional trauma therapy or medication.

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