Midomafetamine

Generic Name: Midomafetamine

Brand Names: -

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.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

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

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

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Lysergic Acid Diethylamide
Drug: 3,4-methylenedioxymethamphetamine
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

A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders

Phase 2

Withdrawn

Conditions: Anorexia Nervosa Restricting Type
Binge-Eating Disorder

Interventions: Drug: Midomafetamine
Behavioral: Non-directive therapy
Behavioral: Therapy

First Posted Date: 2020-07-01

Last Posted Date: 2024-10-31

Lead Sponsor: Lykos Therapeutics

Target Recruit Count: 36

Registration Number: NCT04454684

A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD

Conditions: Post Traumatic Stress Disorder

First Posted Date: 2020-06-18

Last Posted Date: 2024-11-05

Lead Sponsor: Lykos Therapeutics

Registration Number: NCT04438512

Locations: 🇺🇸
Sunstone Medical, PC, Rockville, Maryland, United States
🇺🇸
Pearl Psychedelic Institute, Waynesville, North Carolina, United States

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