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Completed

NCT Number: NCT05948683

Prosocial Effects of MDMA

In this study, the aim is to test the hypothesis that MDMA produces greater prosocial effects when administered in the presence of a familiar, compared to an unfamiliar, person

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

MDMA has shown promise as an adjunct to psychotherapy in the treatment of PTSD and other disorders. When used clinically with psychotherapy, the drug is believed to interact with the interpersonal components of the psychotherapy, especially the patient-therapist interaction. Indeed, patients and therapists usually form a strong alliance during several preparatory sessions, even before a drug is administered. Experts believe that the patient's familiarity and trust of the therapist is critical to the success of the intervention. Whereas therapeutic alliance is critical to the success of any psychotherapy, it may be especially important when psychoactive drugs are part of the treatment. The importance of this trust-building component preceding drug-assisted therapy has not been investigated.

There are mechanistic reasons to expect that MDMA will be more effective when a patient interacts with a familiar and trusted other person, compared to a stranger. MDMA is thought to exert its "prosocial" effects by increasing the social bonding hormone, oxytocin, and this hormone may contribute to its therapeutic effects. However, there is evidence that oxytocin increases feelings of connectedness specifically with familiar "in-group" members, and that it may not produce affiliative effects with individuals who are unfamiliar, or perceived to be outside their groups. Thus, the pro-social effects of oxytocin may depend on the degree of familiarity and closeness of the interacting partner. As noted above, during preparatory sessions in drug-assisted psychotherapy the patient forms a bond with a therapists before the drug is administered, which may serve to increase the 'in-group' effect of the drug, and thus maximize the therapeutic potential of the MDMA.

Controlled laboratory studies (without psychotherapy) show that MDMA produces prosocial effects on measures of mood and socio-emotional function. However, most of these studies are conducted in isolated individuals, or with study partners who have no prior relationship with the participant. In this proposed study the study team will investigate whether the prosocial effects of MDMA are greater when interacting with a partner to whom the participant feels close and more connected, compared to a partner who is unfamiliar.

To establish familiarity in one of the study groups the study team will use a procedure designed to establish feelings of closeness and connectedness between two strangers. In this procedure, two same-sex partners, who are initially strangers, engage in a 45 min conversation with one of two sets of topics provided by the experimenter. In one condition the topics remain superficial ("small talk" condition) and in the other, they become progressively deeper ("deep talk" condition) over the 45 mins. The study team and others have shown that the deep talk condition produces feelings of connection between the partners, and participants report feeling understood and liking their partners.

In the present study, the investigator will use this procedure to establish familiarity between conversation partners. The investigator aims to test the hypothesis that MDMA produces greater prosocial effects when administered in the presence of a familiar, compared to an unfamiliar, person. Participants will participate in four sessions, in which they receive MDMA (100 mg) or a placebo and then engage in a 15-min conversation with a familiar or unfamiliar person.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • used MDMA or psychedelic between 1-40
  • high school diploma or equivalent
  • BMI between 19 and 30
  • verbal fluency in English

Exclusion criteria

  • History of adverse effects with MDMA
  • High blood pressure
  • Any medical condition requiring regular medication
  • Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
  • Women who are pregnant or trying to become pregnant.

Treatment and study plan

MDMA

Drug

The stimulant MDMA

Placebo

Drug

Dextrose

Primary outcomes

  1. Natural Language Processing using large language model

    Time frame: during 15 minute test conversation, occurring 1.5 hours after drug administration

    Differences in speech content across all conditions

  2. Facial expression analysis using HUMEAI software

    Time frame: during 15 minute test conversation, occurring 1.5 hours after drug administration

    Changes in emotional expressions during conversations

Secondary outcomes

  1. Oxytocin

    Time frame: 120 minutes post drug administration

    Changes in oxytocin levels across all conditions

  2. Self-reported feelings of connection using Likert scale conversation questionnaires

    Time frame: Collected at the end of the session, 240 minutes post-drug administration

    ratings of connectedness

  3. Affective touch

    Time frame: Post-drug, 2 hours post-drug administration

    Ratings of pleasantness, intensity and want more touch (1-7) after differing velocities of touch

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Effects of Familiarity on Prosocial Effects of MDMA

Acronym: PEM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2023
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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