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

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.

Intervention / Treatment

  • Drug: MDMA
  • Behavioral: Psychotherapy

Condition or Disease

  • Psychological Effects of Study Drug

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 150 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Nov 01, 2022
Primary Completion: Nov 01, 2024
Completion Date: Dec 01, 2025
Study First Posted: Aug 29, 2019
Results First Posted: Aug 30, 2020
Last Updated: Mar 29, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 18

More Details

NCT Number: NCT04073433
Other IDs: MT2
Study URL: https://ClinicalTrials.gov/show/NCT04073433
Last updated: Jun 16, 2022