Prosocial Effects of MDMA

Brief Summary

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

Intervention / Treatment

  • MDMA (DRUG)
    The stimulant MDMA
  • Placebo (DRUG)
    Dextrose

Condition or Disease

  • MDMA ('Ecstasy')
  • Social Interaction

Phase

  • Early Phase 1
  • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 35 Years
    Enrollment: 34 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 21, 2023 ACTUAL
    Primary Completion: Jun 01, 2024 ESTIMATED
    Completion Date: Jun 01, 2024 ESTIMATED
    Study First Posted: Jul 17, 2023 ACTUAL
    Last Updated: Aug 15, 2023

    Sponsors / Collaborators

    Lead Sponsor: University of Chicago
    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

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

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

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 35
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    This clinical trial is recruiting

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    Primary Outcomes
    • Differences in speech content across all conditions

    • Changes in emotional expressions during conversations

    Secondary Outcomes
    • Changes in oxytocin levels across all conditions

    • ratings of connectedness

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

    More Details

    NCT Number: NCT05948683
    Other IDs: IRB23-0219
    Study URL: https://clinicaltrials.gov/study/NCT05948683
    Last updated: Sep 29, 2023