Prosocial Effects of MDMA

Social Interaction Clinical Trial

— PEM  

Official title:

Effects of Familiarity on Prosocial Effects of MDMA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948683
• Other study ID #: IRB23-0219
• Secondary ID: 5R01DA002812-35
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 21, 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: University of Chicago
• Contact: Hanna Molla
• Phone: 7737023560
• Email: hmolla[@]uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Social Interaction

Intervention

Drug:
• MDMA
The stimulant MDMA
• Placebo
Dextrose

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Oxytocin	Changes in oxytocin levels across all conditions	120 minutes post drug administration
Secondary	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
Secondary	Affective touch	Ratings of pleasantness, intensity and want more touch (1-7) after differing velocities of touch	Post-drug, 2 hours post-drug administration