A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)

PHASE3CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

September 2, 2020

Primary Completion Date

October 30, 2022

Study Completion Date

November 2, 2022

Conditions
Posttraumatic Stress Disorder
Interventions
BEHAVIORAL

Therapy

Standardized non-directive therapy performed by therapist team.

DRUG

Midomafetamine

Administration of 80 to 120 mg midomafetamine HCl, followed by a supplemental half-dose 1.5 to 2 hrs after the initial dose of 40 or 60 mg, respectively, during three sessions of MDMA-assisted psychotherapy.

DRUG

Placebo

Administration of placebo with therapy during three experimental sessions

Trial Locations (14)

10016

New York University, New York

11012

Nautilus Psychiatric Services, New York

29464

Zen Therapeutic Solutions, LLC, Mt. Pleasant

70123

Ray Worthy Psychiatry LLC, New Orleans

80304

Aguazul Bluewater, Inc., Boulder

80525

Wholeness Center, Fort Collins

90004

New School Research, Los Angeles

94122

San Francisco Insight and Integration Center, San Francisco

UCSF, San Francisco

06030

University of Connecticut, Farmington

02446

Trauma Research Foundation, Boston

53705-2222

University of Wisconsin - Madison, Madison

Unknown

Assaf Harofeh Research Fund, Beer Yaaqov

Sheba Fund for Health Services and Research, Tel Litwinsky

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lykos Therapeutics

INDUSTRY