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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Psychological Effects of Study Drug

Intervention / Treatment
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* Drug: Midomafetamine
* Behavioral: Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDMA-assisted therapy<br>One session of MDMA-assisted therapy with a dose of MDMA 120 mg and optional supplemental dose of 60 mg 1.5 to 2 hours later | Drug: Midomafetamine<br>* 120 mg MDMA<br>* Other names: MDMA;Behavioral: Therapy<br>* Non-directive therapy conducted during MDMA-assisted therapy session<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mood, Subjective Effects, MDMA