What side effects are associated with this type of intervention?

MDMA (Ecstasy) treatments, which enhance mood, empathy, and social bonding by increasing serotonin, dopamine, and norepinephrine release, can cause several side effects. Common side effects include increased heart rate, blood pressure, and body temperature, potentially leading to dehydration and hyperthermia. Psychological effects may include anxiety, paranoia, and depression, especially during the comedown period. Long-term use can result in neurotoxicity, affecting memory and cognitive function, and has been associated with cardiotoxicity, impacting heart health.

What prior FDA approvals exist?

The FDA has not approved any drugs specifically for the treatment of Ecstasy (MDMA) use or its effects. However, MDMA itself is currently being studied in clinical trials for its potential therapeutic benefits, particularly in the context of MDMA-assisted psychotherapy for PTSD. These trials explore MDMA's ability to increase the release of serotonin, dopamine, and norepinephrine, which can enhance mood, empathy, and social bonding. Other related treatments that affect these neurotransmitters include SSRIs and SNRIs, which are approved for depression and anxiety but not specifically for Ecstasy-related conditions.

What other types of research exist?

Promising novel alternatives to MDMA for enhancing mood, empathy, and social bonding include psilocybin, which has shown potential in clinical trials for treating anxiety and depression, and ketamine, which is being explored for its rapid antidepressant effects. Both substances influence neurotransmitter systems related to mood and social behavior. Additionally, research into synthetic compounds like 5-MeO-DMT and novel serotonergic psychedelics may offer future alternatives.

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Other

MDMA for Social Interactions (PEM Trial)

Q: What is the mechanism of action of this treatment?

MDMA (Ecstasy) increases the release of serotonin, dopamine, and norepinephrine, which enhances mood, empathy, and social bonding. This mechanism is important for patients because it helps explain both the therapeutic potential and the risks associated with MDMA use. Treatments targeting these neurotransmitter systems aim to mitigate adverse effects such as neurotoxicity and mood disturbances while harnessing the prosocial and mood-enhancing benefits of MDMA.

Phase < 1

Waitlist Available

Led By Harriet de Wit

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during 15 minute test conversation, occurring 1.5 hours after drug administration

Summary

This trial tests if MDMA makes people feel more connected when they talk to someone they know well compared to a stranger. The study focuses on patients in therapy, especially those with trauma, to see if the drug helps them feel more trusting and connected during their sessions. MDMA was used legally by doctors in the US and Switzerland for several decades to enhance therapy, showing early promise in treating trauma-related disorders.

Who is the study for?

This trial is for adults with a BMI of 19-30 who have used MDMA or psychedelics at least once but not more than 40 times, have completed high school education, and are fluent in English. People with recent serious mental health diagnoses, high blood pressure, pregnant women, those trying to conceive, individuals on regular medication or with a history of bad reactions to MDMA cannot participate.

What is being tested?

The study investigates whether MDMA can enhance social bonding when taken around someone familiar versus an unfamiliar person. Participants will receive either MDMA or a placebo without knowing which one they've received to compare the effects on social interactions.

What are the potential side effects?

MDMA may cause side effects like anxiety, headache, nausea, increased heart rate and blood pressure changes. It might also lead to emotional sensitivity and altered sensory perceptions during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 15 minute test conversation, occurring 1.5 hours after drug administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during 15 minute test conversation, occurring 1.5 hours after drug administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and during 15 minute test conversation, occurring 1.5 hours after drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Facial expression analysis using HUMEAI software

Natural Language Processing using large language model

Secondary study objectives

Affective touch

Oxytocin

Self-reported feelings of connection using Likert scale conversation questionnaires

Trial Design

4Treatment groups

Experimental Treatment

Group I: Unfamiliar partner with placeboExperimental Treatment1 Intervention

Participant engages in social interaction with 'unfamiliar' partner under placebo

Group II: Unfamiliar partner with MDMAExperimental Treatment1 Intervention

Participant engages in social interaction with 'unfamiliar' partner under MDMA

Group III: Familiar partner with placeboExperimental Treatment1 Intervention

Participant engages in social interaction with 'familiar' partner under placebo

Group IV: Familiar partner with MDMAExperimental Treatment1 Intervention

Participant engages in social interaction with 'familiar' partner under MDMA

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MDMA

2023

Completed Phase 2

~410

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

MDMA (Ecstasy) increases the release of serotonin, dopamine, and norepinephrine, which enhances mood, empathy, and social bonding. This mechanism is important for patients because it helps explain both the therapeutic potential and the risks associated with MDMA use. Treatments targeting these neurotransmitter systems aim to mitigate adverse effects such as neurotoxicity and mood disturbances while harnessing the prosocial and mood-enhancing benefits of MDMA.