Therapeutic Psychedelics


MDMA has its roots in North American indigenous culture. MDMA was first derived from safrole oil which can be produced from the root bark of the Sassafras tree (Sassafras albidum), common to North American deciduous forests. Early American settlers learned about extracting safrole oil from Sassafras trees from Native American medicine people who had found multiple uses for different parts of the tree .

3,4-methylenedioxymethamphetamine (MDMA) was first synthesized in 1912. It has been available as a synthetic drug since that time. It became popular as a legal alternative to a similar recreational drug (MDA) that was made illegal in 1970. In the U.S., a few dozen psychotherapists used MDMA to assist their treatment from 1977 - 1985, before it too was made illegal. MDMA is commonly referred to as "Ecstasy" or "Molly" in the underground scene. However, illegally purchased Ecstasy or Molly may not contain pure MDMA.

MDMA is still illegal, but robust FDA-approved trials over the last 20 years are opening a path toward FDA approval of MDMA for use in the treatment of PTSD. Most recent estimates suggest that MDMA may achieve FDA approval in the United States in 2024.



MDMA appears to work through a number of psychological mechanisms facilitating the processing of emotional trauma, and like other substances used in psychedelic-assisted therapies, encourage brain plasticity - the growth of connections between neurons.

Condition Evidence Level Type of Evidence
PTSD B Randomized Controlled Trials (1 or more)
PTSD and PTSD with Eating Disorder B Randomized Controlled Trials (1 or more)



Because MDMA causes changes including increased sensitivity to touch, sexual and sensual feelings, and the desire to be touched - it is critical that appropriate protocols are in place to reduce risk of care provider abuse.

MDMA-assisted therapy in clinical trials requires screening for prior mental health history and medication use. Prior history and medications would need to be reviewed with the involved provider.

When used as a "party drug" - it is often mixed with other substances that can increase risk.



MDMA is a schedule 1 drug under the Controlled Substances Act - this indicates significant potential for abuse, although some find this designation controversial. MDMA is not legal for medical use in the United States, except when used in FDA-approved trials. Multidisciplinary Association for Psychedelic Studies (MAPS) - created by Dr. Rick Doblin in 1986, has led the efforts in studying MDMA-assisted therapy for PTSD. From 2004 - 2008 an FDA approved Stage 1- Double blind study was conducted. In 2021 results were published from the first Phase 3 trial. The second, larger Phase 3 trial completed in fall 2022 and MAPS plans to publish their most recent data in the fall of 2023. Then the next step would be to apply for FDA approval. Subsequent steps would then be taken by the DEA and then by some state governments, depending on the state.

Australia recently approved MDMA as a treatment for PTSD, but the drug will continue to be very restricted.

Psycho-Therapeutic Use


Currently, access to therapeutic use of MDMA is only available through participation in FDA approved trials. MAPS Treatment Protocol currently used in all their FDA-Approved Clinical Trials is as follows:

Study Treatment Protocol

  • Initial Screening/Enrollment
  • 3 Preparation Sessions
  • 1 Experimental session with 80mg MDMA
  • (two-person team of therapists)
  • 3 Integration Sessions
  • 1 Experimental session with 80-120 mg MDMA (two-person team of therapists)
  • 3 integration sessions
  • 1 Experimental session with 80 -or 120mg MDMA (two-person team of therapists)
  • 3 integration sessions
  • 2-month Follow-up

Reynolds, 2023

Reardon, 2023

DEA, 2020