A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least severe PTSD.

The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms?

Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy.

Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.

Conditions

• Posttraumatic Stress Disorder

Interventions

BEHAVIORAL

Therapy

Non-directive therapy performed by therapist team

DRUG

midomafetamine HCl

Administration of 80 to 120 mg midomafetamine HCl, followed by a supplemental dose 1.5 to 2 hrs later of 40 or 60 mg midomafetamine HCl, respectively, during three experimental sessions

DRUG

Placebo

Administration of placebo during three experimental sessions

Sponsors & Collaborators

• Lykos Therapeutics

  lead INDUSTRY

Principal Investigators

• Casey Paleos, MD · Affective Care

• Bessel van der Kolk, MD · Trauma Research Foundation

• Emma Hapke, MD · Dr. Simon Amar, Inc.

• Revital Amiaz, MD · The Chaim Sheba Medical Center, Tel Hashomer Hospital

• Michael Bogenschutz, MD · New York University/Langone Medical Center/Bellevue Hospital

• Randall Brown, MD, PhD · University of Wisconsin, Madison

• Sylvestre Quevedo, MD · San Francisco Insight and Integration Center

• Josh Woolley, MD, PhD · University of California, San Francisco

• Ray Worthy, MD · Ray Worthy Psychiatry, LLC

• Cole Marta, MD · New School Research, LLC

• Scott Shannon, MD · Wholeness Center

• Wael Garas, MD · Aguazul-Bluewater, Inc.

• Yevgeniy Gelfand, MD · Zen Therapeutics Solutions, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-21

Primary Completion

2020-08-11

Completion

2020-08-21

FDA Drug

Yes

Countries

• United States
• Canada
• Israel

Study Locations