NCT03790618

Brief Summary

The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
5 years until next milestone

Results Posted

Study results publicly available

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

November 30, 2018

Results QC Date

June 14, 2022

Last Update Submit

March 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Responses to Affective Touch

    Participants will complete an affective touch task during which time they will rate pleasantness of touch on a likert scale of 1-7, with higher scores indicating greater ratings of pleasantness

    End of study (time 0 and approximately six weeks later)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Subjects will attend one session during which they will receive a placebo capsule.

Drug: 3,4-MethylenedioxymethamphetamineDrug: methamphetamine

Low dose MDMA

EXPERIMENTAL

Subjects will attend one session during which they will receive 0.75mg/kg MDMA.

Drug: 3,4-MethylenedioxymethamphetamineDrug: methamphetamine

High dose MDMA

EXPERIMENTAL

Subjects will attend one session during which they will receive 1.5mg/kg MDMA.

Drug: 3,4-MethylenedioxymethamphetamineDrug: methamphetamine

Methamphetamine

EXPERIMENTAL

Subjects will attend one session during which they will receive 20mg methamphetamine.

Drug: 3,4-MethylenedioxymethamphetamineDrug: methamphetamine

Interventions

Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

High dose MDMALow dose MDMAMethamphetaminePlacebo

Please see above.

High dose MDMALow dose MDMAMethamphetaminePlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • High school degree
  • English fluency
  • Healthy
  • Has used MDMA

You may not qualify if:

  • Pregnant or trying to become pregnant
  • Any medical or psychiatry condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Bershad AK, Hsu DT, de Wit H. MDMA enhances positive affective responses to social feedback. J Psychopharmacol. 2024 Mar;38(3):297-304. doi: 10.1177/02698811231224153. Epub 2024 Jan 27.

MeSH Terms

Interventions

Methamphetamine

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Harriet de Wit
Organization
University of Chicago

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 31, 2018

Study Start

June 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

January 5, 2024

Results First Posted

January 5, 2024

Record last verified: 2023-03

Locations