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

A Phase 1, Open-Label, Multi-Site Study to Assess Psychological Effects of MDMA-Assisted Psychotherapy When Administered to Healthy Volunteers

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.

Study Overview

• Status: Withdrawn
• Conditions: Psychological Effects of Study Drug
• Intervention / Treatment: Behavioral: Therapy; Drug: Midomafetamine HCl

Detailed Description

The Phase 1, randomized, placebo-controlled study MT1 was designed to collect safety and quantitative data on mood, psychological symptoms, personality traits, and interpersonal closeness in therapists learning to conduct MDMA-assisted psychotherapy or MDMA research among 120 healthy volunteers. The MT1 study was also designed to expand the knowledge of therapists training to conduct MDMA-assisted psychotherapy research. In the MT1 study, several participants submitted optional written narratives with impressions that participating in MDMA-assisted psychotherapy helped them professionally and personally.

This Phase 1, open-label, multi-site research study is designed to build upon the MT1 study to further assess the psychological effects and safety of manualized MDMA-assisted psychotherapy, while supporting the expansion of knowledge for treatment providers who are learning to conduct MDMA-assisted psychotherapy or MDMA research. This study is intended to look further into the personal and professional benefits spontaneously reported in narratives to the site team from the MT1 study participants. This will be done by collecting changes in self-compassion, burnout, professional quality of life, psychological inflexibility, and mood using validated measures in a larger sample of treatment providers, allowing for effect size calculations.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDMA-assisted therapy; 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	Behavioral: Therapy; Non-directive therapy conducted during MDMA-assisted therapy session; Drug: Midomafetamine HCl; 120 mg midomafetamine HCl; Other Names: MDMA; 3,4-methylenedioxymethamphetamine; midomafetamine; MDMA HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lykos Therapeutics
• Investigators: Principal Investigator: Marcela Ot'alora, Private Practice

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: MDMA; Mood; Subjective Effects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Adrenergic Agents; Neurotransmitter Uptake Inhibitors; Adrenergic Uptake Inhibitors; Serotonin Agents; Hallucinogens; N-Methyl-3,4-methylenedioxyamphetamine
• Other Study ID Numbers: MT2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No