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

Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans

Phase 2

Withdrawn

Conditions: PTSD

Interventions: Drug: Midomafetamine
Behavioral: Therapy

First Posted Date: 2021-12-30

Last Posted Date: 2024-10-30

Lead Sponsor: Lykos Therapeutics

Registration Number: NCT05173831

Food Effects on Bioavailability of MDMA in Healthy Volunteers

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: midomafetamine

First Posted Date: 2021-12-07

Last Posted Date: 2024-10-30

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 14

Registration Number: NCT05147402

Locations: 🇺🇸
Alliance for Multispecialty Research LLC, Knoxville, Tennessee, United States

Social Anxiety MDMA-Assisted Therapy Investigation

Phase 2

Active, not recruiting

Conditions: Social Anxiety Disorder

Interventions: Drug: MDMA
Behavioral: Psychotherapy

First Posted Date: 2021-11-30

Last Posted Date: 2024-04-19

Lead Sponsor: Jason B Luoma

Target Recruit Count: 90

Registration Number: NCT05138068

Locations: 🇺🇸
Portland Psychotherapy Clinic, Research, & Training Center, Portland, Oregon, United States

Drug Effects on Interpersonal Interaction

Early Phase 1

Completed

Conditions: Interaction, Social

Interventions: Drug: MDMA
Drug: placebo oral tablet

First Posted Date: 2021-11-17

Last Posted Date: 2022-06-15

Lead Sponsor: University of Chicago

Target Recruit Count: 30

Registration Number: NCT05123716

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)

Phase 2

Completed

Conditions: Post Traumatic Stress Disorder

Interventions: Drug: MDMA

First Posted Date: 2021-10-05

Last Posted Date: 2024-11-14

Lead Sponsor: Remedy

Target Recruit Count: 10

Registration Number: NCT05067244

Locations: 🇨🇦
Remedy Institute, Toronto, Ontario, Canada

Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

Phase 2

Withdrawn

Conditions: Posttraumatic Stress Disorder

Interventions: Drug: midomafetamine
Behavioral: Therapy

First Posted Date: 2021-07-20

Last Posted Date: 2024-11-01

Lead Sponsor: Lykos Therapeutics

Registration Number: NCT04968938

Effects of MDMA-like Substances in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: 3,4-methylenedioxymethamphetamine
Drug: lysine-3,4-methylenedioxyamphetamine
Drug: 3,4-methylenedioxyamphetamine
Drug: lysine-3,4-methylenedioxymethamphetamine
Other: Placebo

First Posted Date: 2021-04-19

Last Posted Date: 2024-08-14

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 23

Registration Number: NCT04847206

Locations: 🇨🇭
University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland

Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD

Phase 2

Completed

Conditions: PTSD

Interventions: Drug: Midomafetamine
Behavioral: Psychotherapy

First Posted Date: 2021-03-05

Last Posted Date: 2024-11-05

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 26

Registration Number: NCT04784143

Locations: 🇺🇸
James J. Peters VA Medical Center, Bronx, New York, United States

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

Phase 3

Completed

Conditions: PTSD

Interventions: Drug: Midomafetamine HCl

First Posted Date: 2021-01-19

Last Posted Date: 2024-11-28

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 87

Registration Number: NCT04714359

Locations: 🇺🇸
New School Research, Los Angeles, California, United States
🇺🇸
Aguazul-Blue Water Inc., Boulder, Colorado, United States
🇺🇸
Wholeness Center, Fort Collins, Colorado, United States

and more 11 locations

Effects of MDMA Co-administration on the Response to LSD in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: 3,4-methylenedioxymethamphetamine
Drug: Lysergic Acid Diethylamide
Other: MDMA Placebo
Other: LSD Placebo

First Posted Date: 2020-08-18

Last Posted Date: 2022-08-23

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 24

Registration Number: NCT04516902

Locations: 🇨🇭
University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland

Drug Development Updates

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