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

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 21, 2018

Primary Completion Date

August 11, 2020

Study Completion Date

August 21, 2020

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

Trial Locations (15)

10016

New York University, New York

10024

New York Private Practice, New York

29464

Zen Therapeutic Solutions, LLC, Mt. Pleasant

53705

University of Wisconsin at Madison, Madison

70123

Ray Worthy Psychiatry LLC, New Orleans

80302

Aguazul-Blue Water Inc., Boulder

80525

Wholeness Center, Fort Collins

91601

New School Research LLT, North Hollywood

94114

San Francisco Insight and Integration Center, San Francisco

94122

University of California San Francisco, San Francisco

02446

Trauma Research Foundation, Boston

V5R 5H3

Providence Health Center, Vancouver

H2W1Y9

Dr. Simon Amar, Inc., Montreal

Unknown

Assaf Harofeh Research Fund, Be’er Ya‘aqov

Sheba Fund for Health Services and Research, Tel Litwinsky

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lykos Therapeutics

INDUSTRY