A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

PHASE3CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

March 8, 2021

Primary Completion Date

November 1, 2023

Study Completion Date

November 6, 2023

Conditions
PTSD
Interventions
DRUG

Midomafetamine HCl

Initial doses per Experimental Session include 80 mg or 120 mg midomafetamine HCl, followed 1.5 to 2 hours later by a supplemental dose unless tolerability issues emerge. For an initial dose of 80 mg, a 40 mg supplemental dose will be used. For an initial dose of 120 mg, a 60 mg supplemental dose will be used. Total amounts of midomafetamine HCl to be administered per Experimental Session range from 80 mg to 180 mg.

Trial Locations (15)

10016

NYU, New York

11012

New York Private Practice, New York

29464

Zen Therapeutic Solutions, LLC, Mt. Pleasant

70123

Ray Worthy Psychiatry, New Orleans

80302

Aguazul-Blue Water Inc., Boulder

80525

Wholeness Center, Fort Collins

90004

New School Research, Los Angeles

94114

San Francisco Insight and Integration Center, San Francisco

94122

UCSF, San Francisco

02446

Trauma Research Foundation, Boston

53705-2222

University of Wisconsin - Madison, Madison

V5R 5H3

Numinus, Vancouver

H2W 1Y9

Numinus, Montreal

Unknown

Beer Yaakov Mental Health Center, Beer Yaaqov

Tel Hashomer, Tel Aviv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lykos Therapeutics

INDUSTRY

NCT04714359 - A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD | Biotech Hunter | Biotech Hunter