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

• ClinicalTrials.gov Identifier: NCT04073433
• Recruitment Status: Not yet recruiting
• First Posted: August 29, 2019
• Last Update Posted: November 16, 2020
• Sponsor: Multidisciplinary Association for Psychedelic Studies
• Information provided by (Responsible Party): Multidisciplinary Association for Psychedelic Studies

Study Description

Brief Summary:

The purpose of this multi-site study is to collect information to support the safety profile of MDMA-assisted psychotherapy and to collect quantitative data on mood, psychological status, self-compassion, professional quality of life, and professional burnout in healthy volunteers after MDMA administration within a therapeutic setting. This exploratory study will permit an understanding of the acute effects of the drug in a specific and relevant setting for use in therapy.

Condition or disease	Intervention/treatment	Phase
Psychological Effects of Study Drug	Drug: MDMA; Behavioral: Psychotherapy	Phase 1

Detailed Description:

3,4-methylenedioxymethamphetamine (MDMA) produces changes in feelings and thoughts. It appears to have a unique pharmacological profile distinct from psychostimulants and classical hallucinogenic (psychedelic) compounds. Its unique properties have led to interest in using it in combination with psychotherapy. So far, studies in healthy volunteers have examined the effects of MDMA in a laboratory setting rather than a psychotherapeutic setting.

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. Compassion fatigue and burnout are associated with job-related stress and are known to impact professional quality of life. In addition, continued training for new treatment providers, including the option for their own MDMA experience, is vital as the research for MDMA-assisted psychotherapy for PTSD expands in the United States. This study is not a registration study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open-Label, Multi-Site Study to Assess Psychological Effects of MDMA-Assisted Psychotherapy When Administered to Healthy Volunteers
• Estimated Study Start Date: December 2020
• Estimated Primary Completion Date: November 2024
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental: MDMA-assisted psychotherapy; One session of MDMA-assisted psychotherapy with a dose of MDMA 120 mg and optional supplemental dose of 60 mg 1.5 to 2 hours later	Drug: MDMA; 120 mg MDMA; Other Name: 3,4-methylenedioxymethamphetamine; Behavioral: Psychotherapy; Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in Self Compassion Scale (SCS) total score [ Time Frame: 9 weeks post-enrollment ]
   Self Compassion Scale (SCS) total score, a 26-item self-report measure of self-compassion

Eligibility Criteria

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

Criteria

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] 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

Contacts and Locations

Contacts

Contact: Melissa Field; (215) 645-2466; recruitment@mapsbcorp.com

Sponsors and Collaborators

Multidisciplinary Association for Psychedelic Studies

Investigators

• Study Director: Michael Mithoefer, MD; MAPS Public Benefit Corp.

More Information

• Responsible Party: Multidisciplinary Association for Psychedelic Studies
• ClinicalTrials.gov Identifier: NCT04073433
• Other Study ID Numbers: MT2
• First Posted: August 29, 2019
• Last Update Posted: November 16, 2020
• Last Verified: September 2020

• 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

Keywords provided by Multidisciplinary Association for Psychedelic Studies:

Mood; Subjective Effects; MDMA

Additional relevant MeSH terms:

N-Methyl-3,4-methylenedioxyamphetamine; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Agents