MDMA for Social Interactions

(DEI Trial)

Overseen By Matthew Bona

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Chicago

Disqualifiers: Medical condition, Pregnancy, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how MDMA (also known as Ecstasy or Molly) affects feelings of closeness during conversations. Participants will converse with a new partner under the influence of MDMA in one session and a placebo (an inactive substance) in another. Afterward, they will indicate which partner they felt closer to. Individuals who speak English, have at least a high school education, and have a BMI between 19 and 30 might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how MDMA works in people, offering participants a unique opportunity to contribute to groundbreaking scientific knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since it involves MDMA, it's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MDMA may pose some safety concerns. Studies have found that MDMA can affect the heart, brain, kidneys, and liver, and these effects can sometimes be serious. MDMA, also known as a party drug or "ecstasy," has been misused, meaning it has been used in unsafe or unapproved ways.

Some people have reported feeling dizzy or sleepy after taking MDMA. In some cases, harmful effects have occurred if swallowed, touched, or inhaled. Despite these risks, scientists are interested in studying MDMA's potential benefits in controlled settings like clinical trials.

The current trial is in an early stage, marking one of the first steps in assessing MDMA's safety for new uses. This stage focuses on understanding how the treatment affects people and what side effects might occur. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MDMA as a treatment for interpersonal interaction issues because it acts on serotonin receptors to enhance mood and empathy, which is different from the typical antidepressants that primarily focus on balancing neurotransmitters like serotonin, norepinephrine, and dopamine. Unlike standard therapies that can take weeks to demonstrate effectiveness, MDMA has the potential to show positive effects in just a few hours, offering quicker relief. Additionally, MDMA is administered in a controlled setting, providing a unique approach that combines pharmacological effects with therapeutic guidance, potentially leading to more effective and lasting improvements in interpersonal interactions.

What evidence suggests that MDMA could be an effective treatment for enhancing social connection?

Research shows that MDMA, a treatment in this trial, can increase feelings of empathy and connection, potentially improving interactions with others. Studies on MDMA-assisted therapy have found it greatly reduces PTSD symptoms, helping individuals feel more connected and safe. This suggests MDMA might enhance closeness and openness during conversations. Although limited data exists on using MDMA specifically to improve social interactions, its capacity to boost empathy and emotional openness is promising. Participants in this trial will receive either MDMA or a placebo in different sessions to evaluate these effects. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

High school level education

English fluency

You are between 19 and 30.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage in two sessions: one with MDMA and one with placebo, each involving a 45-minute conversation with a partner

1 week

2 visits (in-person)

Test Session

Participants complete an online test session to assess preference for partners after the drug sessions

1 day

1 visit (online)

Follow-up

Participants are monitored for mood states and feelings of closeness and connection after the sessions

72 hours

What Are the Treatments Tested in This Trial?

Interventions

• MDMA
• placebo oral tablet

How Is the Trial Designed?

Group I: Experimental: Placebo Then MDMA Experimental Treatment 2 Interventions

Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 100 mg MDMA.

Group II: Experimental: MDMA Then Placebo Experimental Treatment 2 Interventions

Participants first receive 100 mg MDMA at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo.

MDMA is already approved in United States for the following indications:

Approved in United States as MDMA for:

• Posttraumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

MDMA, commonly known as ecstasy, is often mistakenly believed to be a safe drug, but its use has led to significant health risks, including serious cardiovascular effects and long-term neuropsychiatric issues.

The review highlights the increasing prevalence of ecstasy use among teenagers and young adults, emphasizing the need for awareness of its potential for toxicity and the importance of proper emergency care for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ecstasy toxicity]. Reingardiene, D.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6435835/

A Review of 3,4-methylenedioxymethamphetamine (MDMA) It is shorter-acting, which makes it more clinically manageable, it enhances feelings of empathy and bonding and allows users to access and process memories of ...

2. nature.com nature.com/articles/s41591-023-02565-4

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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278584619301484

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 ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538482/

3,4-Methylenedioxymethamphetamine (MDMA) Toxicity - NCBI This course sheds light on clinical aspects of MDMA use, emphasizing its potential life-threatening impact on cardiovascular, neurological, renal, and hepatic ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20230681

MDMA and MDMA-Assisted Therapy | American Journal of ... A considerable body of preliminary evidence suggests that MDMA-AT delivered in a controlled clinical setting is a safe and efficacious treatment for PTSD.

6. sigmaaldrich.com sigmaaldrich.com/IL/en/sds/sigma/m6403?srsltid=AfmBOopg_iXdUAx-yeLHSRc1_ZmJtSFygVRrnaRVcempZ8dGMwg7c3Rb

SAFETY DATA SHEET This product is toxic if swallowed and may cause drowsiness or dizziness. Avoid breathing dust/fume/gas/mist/vapors/spray. Use only outdoors or ...

7. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/13971m.pdf

Safety Data Sheet 3,4-MDMA (hydrochloride) is fatal if swallowed, in contact with skin, or if inhaled. Do not breathe dust/fume/gas/mist/vapors/spray.

8. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/3_4-Methylenedioxymethamphetamine

3,4-Methylenedioxymethamphetamine | C11H15NO2 | CID 1615 3,4-Methylenedioxymethamphetamine (MDMA) is a widely abused illicit drug that can cause severe and even fatal adverse effects. However, interest remains for its ...

9. dl.novachem.com.au dl.novachem.com.au/sds/assets/novachem.sds.M-013.pdf

3,4-Methylenedioxymethamphetamine - Novachem Wear full body protective clothing with breathing apparatus. Personal Protective Equipment advice is contained in Section 8 of the SDS. SECTION ...