MDMA-Assisted Psychotherapy for PTSD: Boulder, Colorado (Intern Study)

The next phase (Phase 3) of our clinical development plan for MDMA-assisted psychotherapy for PTSD will require many more co-therapist teams than are currently available. Finding a cost-effective and sustainable way to recruit effective therapists is therefore a top priority.

In this pilot study, we are investigating the effectiveness of MDMA-assisted psychotherapy for PTSD when one member of the standard co-therapist team is a healthcare intern (being trained in therapy, social work, or nursing). The other member of each team is a professional therapist trained in our treatment method. As interns work at a lower cost than fully-licensed therapists, this approach may help reduce costs and train the next generation of psychedelic therapists.

Principal Investigator: Marcela Ot'alora, M.A., L.P.C.

Co-Investigator: Jim Grigsby, Ph.D.

Sub-Investigator/Study Physician: Will Van Derveer, M.D.

Sub-Investigator: Alison McQueen, M.A., L.P.C.

Sub-Investigator: Bruce Poulter, R.N., M.P.H.

Sub-Investigator: Saj Razvi, M.A., L.P.C.

Sub-Investigator: Sandra Van Derveer, M.A.

Intern Investigator: Sara Giron, M.A.

Location: Boulder, CO

Subjects were U.S. veterans with PTSD, mostly from Iraq, Afghanistan, or Vietnam, along with survivors of childhood sexual abuse, assault, rape, and others.

This study has been cleared by the Food and Drug Administration and approved by the Drug Enforcement Administration and an Institutional Review Board.

On October 29, 2018, the results of the largest-ever U.S. Food and Drug Administration (FDA)-regulated clinical trial of MDMA-assisted psychotherapy for the treatment of chronic posttraumatic stress disorder (PTSD) were published in the peer-reviewed Journal of Psychopharmacology. Sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the double-blind, placebo-controlled, Phase 2 pilot study in 28 participants found that one month after their second day-long experimental session, 42.9% in the active-dose (100 mg and 125 mg) MDMA groups did not qualify for a diagnosis of PTSD, compared to 33.3% in the low-dose MDMA (40 mg active placebo) control group. The results were even more notable 12 months after the third active-dose experimental session, which found that one year following treatment with MDMA-assisted psychotherapy, 76% of participants no longer had PTSD.

$802,000 estimated study cost • $802,000 raised • funding complete

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