Healthy, MDMA ('Ecstasy')
Conditions
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.
Interventions
Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
DRUGmethamphetamine
Please see above.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* High school degree * English fluency * Healthy * Has used MDMA
Exclusion criteria
* Pregnant or trying to become pregnant * Any medical or psychiatry condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responses to Affective Touch | End of study (time 0 and approximately six weeks later) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subjects will attend one session during which they will receive a placebo capsule.
3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
methamphetamine: Please see above. | 9 |
| Low Dose MDMA Subjects will attend one session during which they will receive 0.75mg/kg MDMA.
3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
methamphetamine: Please see above. | 9 |
| High Dose MDMA Subjects will attend one session during which they will receive 1.5mg/kg MDMA.
3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
methamphetamine: Please see above. | 9 |
| Methamphetamine Subjects will attend one session during which they will receive 20mg methamphetamine.
3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
methamphetamine: Please see above. | 9 |
| Total | 36 |
Baseline characteristics
| Characteristic | Placebo | Low Dose MDMA | High Dose MDMA | Methamphetamine | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 36 Participants |
| Education - High School Education | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 20 Participants |
| Region of Enrollment United States | 9 participants | 9 participants | 9 participants | 9 participants | 36 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
Primary
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
Time frame: End of study (time 0 and approximately six weeks later)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Responses to Affective Touch | -1.24 units on a scale | Standard Deviation 3.22 |
| Low Dose MDMA | Responses to Affective Touch | 0.12 units on a scale | Standard Deviation 3.14 |
| High Dose MDMA | Responses to Affective Touch | 0.19 units on a scale | Standard Deviation 2.25 |
| Methamphetamine | Responses to Affective Touch | 0.25 units on a scale | Standard Deviation 2.68 |