Drug Effects on Interpersonal Interaction

(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

30 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug MDMA (Ecstasy) in clinical trials?

Research shows that MDMA can produce feelings of euphoria, closeness to others, and heightened senses, which may be beneficial in therapeutic settings. However, it also causes increased heart rate and blood pressure, and its long-term effects are not well understood, suggesting the need for careful consideration in its use. ^{1 2 3 4 5}

Is MDMA generally safe for humans?

MDMA, also known as Ecstasy or Molly, has been associated with various health risks, including heart problems, serotonin syndrome (a potentially life-threatening condition caused by too much serotonin in the brain), and long-term brain effects. There have been reports of overdoses and deaths linked to its use, especially when mixed with other substances like alcohol. Additionally, MDMA tablets can sometimes contain harmful contaminants. ^{6 7 8 9 10}

How does the drug MDMA differ from other treatments?

MDMA is unique because it increases serotonin levels by blocking its reuptake and inhibiting its breakdown, which can enhance mood and empathy. This mechanism is different from many traditional treatments that do not target serotonin in this way. ^{4 11 12 13 14}

What is the purpose of this trial?

This trial involves participants taking MDMA, a drug that can make people feel more connected. They will have conversations with different partners under each condition. The study aims to see if MDMA makes people feel closer to their conversation partners. MDMA, also known as 3,4-methylenedioxymethamphetamine, has been studied for its potential therapeutic effects, particularly in psychotherapy settings.

Eligibility Criteria

Inclusion Criteria

High school level education

English fluency

You are between 19 and 30.

Timeline

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

Treatment Details

Interventions

• MDMA
• placebo oral tablet

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Human pharmacology of 3,4-methylenedioxymethamphetamine ("ecstasy"): psychomotor performance and subjective effects. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Physiological and subjective responses to controlled oral 3,4-methylenedioxymethamphetamine administration. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy"): the influence of gender and genetics (CYP2D6, COMT, 5-HTT). [2021]

4. England pubmed.ncbi.nlm.nih.gov

Non-linear pharmacokinetics of MDMA ('ecstasy') in humans. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A review of acute effects of 3,4-methylenedioxymethamphetamine in healthy volunteers. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Ecstasy toxicity]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Ecstasy overdoses at a New Year's Eve rave--Los Angeles, California, 2010. [2013]

8. Ireland pubmed.ncbi.nlm.nih.gov

Underreporting of ecstasy use among high school seniors in the US. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

There's something about Molly: The underresearched yet popular powder form of ecstasy in the United States. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

MDMA misrepresentation: an unresolved problem for Ecstasy users. [2013]

11. Germany pubmed.ncbi.nlm.nih.gov

Is ecstasy MDMA? A review of the proportion of ecstasy tablets containing MDMA, their dosage levels, and the changing perceptions of purity. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

3,4-methylenedioxymethamphetamine (ecstasy) decreases inflammation and airway reactivity in a murine model of asthma. [2013]

13. England pubmed.ncbi.nlm.nih.gov

Key interindividual determinants in MDMA pharmacodynamics. [2021]

14. England pubmed.ncbi.nlm.nih.gov

MDMA (ecstasy) inhibition of MAO type A and type B: comparisons with fenfluramine and fluoxetine (Prozac). [2015]