Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)

NCT04073433 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: MT2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers and provide training of therapists. The main question it aims to answer is: Does MDMA-assisted therapy result in personal and professional benefits? Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session.

Conditions

Psychological Effects of Study Drug

Keywords

Mood; Subjective Effects; MDMA

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Self Compassion Scale (SCS) total score

  Self Compassion Scale (SCS) total score, a 26-item self-report measure of self-compassion

  9 weeks post-enrollment

Study Arms (1)

MDMA-assisted therapy

EXPERIMENTAL

One session of MDMA-assisted therapy with a dose of 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later

Drug: Midomafetamine HCl; Behavioral: Therapy

Interventions

Midomafetamine HCl DRUG

120 mg midomafetamine HCl

Also known as: 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine, MDMA HCl

MDMA-assisted therapy

Therapy BEHAVIORAL

Non-directive therapy conducted during MDMA-assisted therapy session

MDMA-assisted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are learning to conduct MDMA-assisted psychotherapy or MDMA research through the MDMA Therapy Training Program
• Are at least 18 years old
• Are fluent in speaking and reading the predominantly used or recognized language of the study site
• Are able to swallow pills
• Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable
• Must agree to inform the investigators within 48 hours if any medical conditions occur or medical procedures are planned
• If of childbearing potential, must have a negative pregnancy test at study entry and prior to the Experimental Session, and must agree to use adequate birth control through 10 days after the Experimental Session
• If nursing, must be willing to dispose of breastmilk from dosing through 5 days after each Experimental Session
• Must not participate in any other interventional clinical trials during the duration of the study
• Must agree to not operate a vehicle for at least 24 hours after initial drug administration.
• Must have transportation available after the Experimental Session and through the following day, for traveling back for the Integrative Session.
• Must commit to medication dosing, therapy, and study procedures
• Are willing to be contacted via telephone for all necessary telephone contacts.

You may not qualify if:

• Are not able to give adequate informed consent
• Have uncontrolled hypertension
• Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] in males and \>460 ms in females corrected by Bazett's formula)
• Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
• Have evidence or history of significant medical disorders
• Have symptomatic liver disease
• Have history of hyponatremia or hyperthermia
• Weigh less than 45 kilograms (kg)
• Are pregnant, or are of childbearing potential and are not practicing an effective means of birth control
• Have any current problematic patterns of alcohol or other substance use

Sponsors & Collaborators

• Lykos Therapeutics: lead

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Therapeutics

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Marcela Ot'alora

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 29, 2019
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10