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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will attend one session during which they will receive a placebo capsule. |
|
| Low dose MDMA | Experimental | Subjects will attend one session during which they will receive 0.75mg/kg MDMA. |
|
| High dose MDMA | Experimental | Subjects will attend one session during which they will receive 1.5mg/kg MDMA. |
|
| Methamphetamine | Experimental | Subjects will attend one session during which they will receive 20mg methamphetamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3,4-Methylenedioxymethamphetamine | Drug | Participants will be given 0.75mg/kg of 1.5mg/kg MDMA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38279662 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Low Dose MDMA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | End of study (time 0 and approximately six weeks later) |
|
period of time was until completion which was six weeks on average.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harriet de Wit | University of Chicago | 7737023560 | dewitlab@yoda.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2015 | Jun 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008694 | Methamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| methamphetamine | Drug | Please see above. |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education - High School Education | Count of Participants | Participants |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| Organic Chemicals |