Midomafetamine

Generic Name: Midomafetamine

Drug Type: Small Molecule

Chemical Formula: C_₁₁H_₁₅NO_₂

CAS Number: 42542-10-9

Unique Ingredient Identifier: KE1SEN21RM

Background: An N-substituted amphetamine analog. It is a widely abused drug classified as a hallucinogen and causes marked, long-lasting changes in brain serotonergic systems. It is commonly referred to as MDMA or ecstasy. It is a widely abused drug classified as a hallucinogen and causes marked, long-lasting changes in brain serotonergic systems.

Indication: Clinical trials are now testing the therapeutic potential of MDMA for post-traumatic stress disorder (PTSD) and anxiety associated with terminal cancer. MDMA is one of the four most widely used illicit drugs in the U.S.

Clinical Trials

MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

Phase 2

Completed

Conditions: Anxiety

Interventions: Drug: Placebo
Drug: Midomafetamine HCl
Behavioral: Therapy

First Posted Date: 2015-04-28

Last Posted Date: 2025-05-15

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 18

Registration Number: NCT02427568

Locations: 🇺🇸
Offices of Philip Wolfson MD, San Anselmo, California, United States

Abuse Liability and Human Pharmacology of Mephedrone

Phase 1

Completed

Conditions: Amphetamine-Related Disorders

Interventions: Drug: Placebo
Drug: Mephedrone
Drug: 3,4-methylenedioxymethamphetamine

First Posted Date: 2014-09-05

Last Posted Date: 2014-12-04

Lead Sponsor: Parc de Salut Mar

Target Recruit Count: 12

Registration Number: NCT02232789

Locations: 🇪🇸
Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar., Barcelona, Spain

Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD

Completed

Conditions: Posttraumatic Stress Disorder

Interventions: Drug: Midomafetamine
Behavioral: Therapy

First Posted Date: 2014-04-03

Last Posted Date: 2024-11-05

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 10

Registration Number: NCT02102802

Locations: 🇺🇸
Offices of Michael Mithoefer, Mount Pleasant, South Carolina, United States

Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

Phase 2

Completed

Conditions: Social Anxiety in Autistic Adults

Interventions: Drug: Placebo
Drug: Midomafetamine HCl
Behavioral: Therapy

First Posted Date: 2013-12-11

Last Posted Date: 2024-11-26

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 12

Registration Number: NCT02008396

Locations: 🇺🇸
Los Angeles Biomedical Research Institute, Torrance, California, United States

Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

Phase 2

Terminated

Conditions: Posttraumatic Stress Disorder

Interventions: Drug: Placebo
Drug: Midomafetamine HCl
Behavioral: Psychotherapy

First Posted Date: 2013-10-09

Last Posted Date: 2025-05-13

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 6

Registration Number: NCT01958593

Locations: 🇨🇦
Offices of Dr. Ingrid Pacey MBBS FRCP[C], Vancouver, British Columbia, Canada

Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study

Early Phase 1

Completed

Conditions: Substance-related Disorder
Healthy
Mood Disorder

Interventions: Drug: Methylphenidate
Drug: Modafinil
Drug: MDMA
Drug: Placebo

First Posted Date: 2013-09-26

Last Posted Date: 2016-01-21

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 24

Registration Number: NCT01951508

Locations: 🇨🇭
University Hospital Basel, Basel, Basel-Stadt, Switzerland

Influence of Bupropion on the Effects of MDMA

Phase 1

Completed

Conditions: Healthy
Substance-related Disorders

Interventions: Drug: MDMA
Drug: Bupropion
Drug: Placebo

First Posted Date: 2013-01-18

Last Posted Date: 2016-01-21

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 16

Registration Number: NCT01771874

Locations: 🇨🇭
University Hospital Basel, Basel, Basel-Stadt, Switzerland

Effects of MDMA and Methylphenidate on Social Cognition

Early Phase 1

Completed

Conditions: Social Cognition

Interventions: Drug: 3,4-Methylenedioxymethamphetamine
Drug: Methylphenidate
Drug: Placebo

First Posted Date: 2012-06-11

Last Posted Date: 2018-12-11

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 30

Registration Number: NCT01616407

Locations: 🇨🇭
University Hospital Basel, Basel, Switzerland

Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: 3,4-Methylenedioxymethamphetamine
Drug: Methylphenidate
Drug: Placebo

First Posted Date: 2011-11-06

Last Posted Date: 2016-01-21

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 16

Registration Number: NCT01465685

Locations: 🇨🇭
University Hospital Basel, Basel, Basel-Stadt, Switzerland

Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial

Phase 2

Completed

Conditions: Posttraumatic Stress Disorder

Interventions: Drug: Midomafetamine
Behavioral: Therapy

First Posted Date: 2011-10-24

Last Posted Date: 2024-01-24

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 3

Registration Number: NCT01458327

Locations: 🇺🇸
Offices of Michael Mithoefer, Mount Pleasant, South Carolina, United States

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