Prosocial Effects of MDMA (PEM)

Effects of Familiarity on 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

Study Overview

• Status: Completed
• Conditions: Social Interaction; MDMA ('Ecstasy')
• Intervention / Treatment: Drug: Placebo; Drug: MDMA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Familiar partner with placebo; Participant engages in social interaction with 'familiar' partner under placebo	Drug: Placebo; Dextrose
Experimental: Familiar partner with MDMA; Participant engages in social interaction with 'familiar' partner under MDMA	Drug: MDMA; The stimulant MDMA
Experimental: Unfamiliar partner with placebo; Participant engages in social interaction with 'unfamiliar' partner under placebo	Drug: Placebo; Dextrose
Experimental: Unfamiliar partner with MDMA; Participant engages in social interaction with 'unfamiliar' partner under MDMA	Drug: MDMA; The stimulant MDMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natural Language Processing using large language model	Differences in speech content across all conditions	during 15 minute test conversation, occurring 1.5 hours after drug administration
Facial expression analysis using HUMEAI software	Changes in emotional expressions during conversations	during 15 minute test conversation, occurring 1.5 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxytocin	Changes in oxytocin levels across all conditions	120 minutes post drug administration
Self-reported feelings of connection using Likert scale conversation questionnaires	ratings of connectedness	Collected at the end of the session, 240 minutes post-drug administration
Affective touch	Ratings of pleasantness, intensity and want more touch (1-7) after differing velocities of touch	Post-drug, 2 hours post-drug administration

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Harriet de Wit, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB23-0219; 5R01DA002812-35 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No