MDMA for Mental Health
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how MDMA, a psychedelic compound, affects mental well-being during therapy sessions. It targets mental health providers training to become MDMA-assisted therapists. The study examines MDMA's potential impact on burnout, confidence, mood, and overall life satisfaction. Eligible participants are healthcare professionals learning MDMA-assisted therapy who are not currently experiencing major changes in psychiatric care. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a unique opportunity to be among the first to explore its effects.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that MDMA, when used in a controlled clinical setting, is generally safe for certain treatments. Studies have found that MDMA-assisted therapy, especially for PTSD, is usually well-tolerated. Most participants experience manageable side effects, such as temporary anxiety or a faster heartbeat.
However, MDMA carries potential risks. It can affect mood and perception, leading to mental health side effects like anxiety or paranoia. Some physical side effects include changes in heart rate and blood pressure. Clinical settings closely monitor these effects to ensure participant safety.
Overall, while MDMA shows promise, understanding both its potential benefits and risks is important. Clinical trials carefully monitor participants to manage any adverse effects.12345Why do researchers think this study treatment might be promising?
MDMA is unique because it offers a new approach to treating mental health conditions like PTSD and depression by enhancing emotional processing and empathy during therapy sessions. Unlike traditional treatments such as SSRIs or cognitive behavioral therapy, MDMA works by increasing the release of neurotransmitters like serotonin and dopamine, which can help patients process traumatic memories more effectively. Researchers are excited about MDMA because it has the potential to produce rapid improvements in symptoms after just one session, providing a faster and potentially more profound relief compared to current options.
What evidence suggests that MDMA might be an effective treatment for mental health?
Research has shown that MDMA therapy has potential in reducing PTSD symptoms. Studies have found that many participants experience significant improvements, with some no longer showing signs of PTSD. MDMA may help by boosting brain chemicals like serotonin, dopamine, and oxytocin, which can lift mood and enhance emotional connections. This trial will involve one session of MDMA-assisted therapy to explore its effects on mental health. Although the study focuses on mental health professionals, positive results for PTSD suggest potential benefits for overall mental health. It is important to remember that these findings come from earlier studies, and more research is underway to understand MDMA's broader effects.36789
Who Is on the Research Team?
Rachel Yehuda
Principal Investigator
Mount Sinai Icahn School of Medicine
Tamar Glatman Zaretsky
Principal Investigator
Mount Sinai Icahn School of Medicine
Are You a Good Fit for This Trial?
This trial is for mental healthcare providers training to become MDMA-assisted therapists. It's designed to see if taking MDMA can improve their well-being and reduce burnout. Participants will have therapy sessions before and after taking the drug.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparatory
Preparatory session with study clinicians and baseline assessments
Treatment
Experimental session with MDMA administered in a controlled therapeutic setting followed by an integrative session the next day
Follow-up
Participants are monitored for safety and effectiveness after treatment, including outcome assessments and study termination
What Are the Treatments Tested in This Trial?
Interventions
- MDMA
Trial Overview
The study tests how a single dose of MDMA, given in a controlled therapeutic setting, affects mental health professionals' mood, self-efficacy, compassion towards themselves, quality of life, and other psychological aspects.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
One session of MDMA-Assisted Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rachel Yehuda
Lead Sponsor
Citations
MDMA-assisted therapy for moderate to severe PTSD
These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well ...
MDMA-Based Psychotherapy in Treatment-Resistant Post ...
MDMA can reduce PTSD symptoms even in treatment-resistant cases by increasing certain neurohormones, ie, dopamine, serotonin, norepinephrine, and oxytocin.
assisted psychotherapy for posttraumatic stress disorder: A ...
MDMA-assisted psychotherapy demonstrated a high rate of clinical response (RR = 3.47, 95% CI: 1.70, 7.06), remission (RR = 2.63, 95% CI: 1.37, 5.02), with a ...
MDMA and MDMA-Assisted Therapy | American Journal of ...
In studies of MDMA-AT for PTSD, six participants had suicidal behavior and a seventh was hospitalized for suicidal ideation.
MDMA's Latest Trial Results Offer Hope for Patients with ...
By the end of the 18-week trial period, 71.2% of the people in the MDMA-assisted therapy group no longer met the diagnostic criteria for PTSD, ...
MDMA (Ecstasy/Molly) | National Institute on Drug Abuse (NIDA)
Learn about MDMA (Molly/Ecstasy), a synthetic drug that alters mood and perception, including its effects and health risks.
Side-effects of mdma-assisted psychotherapy: a systematic ...
First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. J ...
3,4-Methylenedioxymethamphetamine (MDMA) Toxicity - NCBI
Many users incorrectly perceive MDMA as a safe drug with few adverse effects. Tolerance develops rapidly, and those who respond by ingesting ...
Ecstasy, molly, MDMA: What health practitioners need to ...
MDMA is associated with a range of adverse health effects that involve psychiatric and neurological functions, as well as cardiovascular, renal, and hepatic ...
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