Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)
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|ClinicalTrials.gov Identifier: NCT04073433|
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : November 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Psychological Effects of Study Drug||Drug: MDMA Behavioral: Psychotherapy||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
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
120 mg MDMA
Other Name: 3,4-methylenedioxymethamphetamine
Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073433
|Contact: Melissa Field||(215) email@example.com|
|Study Director:||Michael Mithoefer, MD||MAPS Public Benefit Corp.|