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Midomafetamine

DRUG12 trials

Sponsors

Lykos Therapeutics, Bronx VA Medical Center

Conditions

Anorexia Nervosa Restricting TypeBinge-Eating DisorderPTSDPharmacokineticsPost Traumatic Stress DisorderPosttraumatic Stress DisorderStartle Response

Phase 1

Evaluation of MDMA on Startle Response
CompletedNCT03181763
Lykos TherapeuticsStartle Response
Start: 2017-03-14End: 2020-08-01Updated: 2025-03-04
Food Effects on Bioavailability of MDMA in Healthy Volunteers
CompletedNCT05147402
Lykos TherapeuticsPharmacokinetics
Start: 2022-07-28End: 2022-12-05Updated: 2024-10-30

Phase 2

Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial
CompletedNCT01458327
Lykos TherapeuticsPosttraumatic Stress Disorder
Start: 2010-12-15End: 2014-06-27Updated: 2024-01-24
Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
CompletedNCT03282123
Lykos TherapeuticsPTSD
Start: 2017-11-16End: 2019-08-10Updated: 2025-06-05
A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders
WithdrawnNCT04454684
Lykos TherapeuticsAnorexia Nervosa Restricting Type, Binge-Eating Disorder
Start: 2026-02-28End: 2028-08-10Updated: 2024-10-31
Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD
TerminatedNCT04784143
Lykos TherapeuticsPTSD
Start: 2021-11-08End: 2024-06-27Updated: 2025-07-15
Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
WithdrawnNCT04968938
Lykos TherapeuticsPosttraumatic Stress Disorder
Start: 2022-08-31End: 2023-08-31Updated: 2024-11-01
Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
WithdrawnNCT05173831
Lykos TherapeuticsPTSD
Start: 2023-09-30End: 2024-12-31Updated: 2024-10-30
Dose Optimization of MDMA-Assisted Therapy for PTSD
RecruitingNCT06418178
Bronx VA Medical CenterPosttraumatic Stress Disorder
Start: 2025-06-03End: 2029-10-31Target: 60Updated: 2025-06-26

Phase 3

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)
CompletedNCT04077437
Lykos TherapeuticsPosttraumatic Stress Disorder
Start: 2020-09-02End: 2022-11-02Updated: 2025-06-06

Unknown Phase

Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD
CompletedNCT02102802
Lykos TherapeuticsPosttraumatic Stress Disorder
Start: 2014-01-31End: 2015-08-03Updated: 2024-11-05
A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD
NCT04438512
Lykos TherapeuticsPost Traumatic Stress Disorder
Updated: 2024-11-05

Related Papers

Effect of MDMA-assisted therapy on mood and anxiety symptoms in advanced-stage cancer (EMMAC): study protocol for a double-blind, randomised controlled trial.
2024-05-215 citations
MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial
Nature Medicine2023-09-14332 citations
Altered brain activity and functional connectivity after MDMA-assisted therapy for post-traumatic stress disorder
Frontiers in Psychiatry2023-01-1232 citations
MDMA-assisted therapy is associated with a reduction in chronic pain among people with post-traumatic stress disorder
Frontiers in Psychiatry2022-11-037 citations
A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults
Journal of Psychopharmacology2022-02-1545 citations
Study Protocol for “Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study”
Frontiers in Psychiatry2021-10-2074 citations