Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the effects of MDMA on encoding and retrieval of emotional and social memories in healthy young adults. The study will explore the effects on memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.
Here, we aim to investigate the effects of MDMA (1 mg/kg) on the encoding and retrieval of positive, negative, social, and neutral memories. The study will use a between subjects design with three groups (N = 20 per group). Two of the groups will be randomly assigned to receive MDMA before one of the two stages of memory: Encoding (ENC) or Retrieval (RET). The third group will receive placebo only (PLC). All three groups will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and other capsules will contain placebo.
Participants will participate in two sessions: a viewing session during which they will view emotional and neutral stimuli, followed 48 hours later by a retrieval session, during which there will be a surprise memory test with two components (verbally cued recollection and picture recognition). On all sessions subjects will also complete mood questionnaires.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDMA at Memory Encoding | Experimental | 20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo. |
|
| MDMA at Memory Retrieval | Experimental | 20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later.. |
|
| Placebo at both sessions | Placebo Comparator | 20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDMA | Drug | This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Accurately Recalling Visual Stimuli | During encoding, participants were presented with labels that were sometimes followed by pictures. During the first memory test, participant were presented again with all of the labels and asked, "Did you see this picture?" Hit and false alarm rates were then calculated, and memory accuracy was measured by hits minus false alarms. | 90 minutes into Session 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Accurately Recognizing Visual Stimuli | After the cued recollection task, all of the pictures were presented to participants (i.e., the ones that they had seen, as well as the ones that were not seen). Participants were then asked, "Did you see this picture?" Hit and false alarm rates were calculated, and memory accuracy was measured as hits minus false alarms. | 90 minutes into Session 2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harriet de Wit, PhD | University of Chicago | Principal Investigator |
| David Gallo, PhD | University of Chicago | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MDMA at Memory Encoding | 20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo. Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. Placebo |
| FG001 | MDMA at Memory Retrievial | 20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later.. Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. Placebo |
| FG002 | Placebo at Both Sessions | 20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Adult Volunteers-Oral MDMA at Memory Encoding | 20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo. Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. Placebo |
| 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 | Probability of Accurately Recalling Visual Stimuli | During encoding, participants were presented with labels that were sometimes followed by pictures. During the first memory test, participant were presented again with all of the labels and asked, "Did you see this picture?" Hit and false alarm rates were then calculated, and memory accuracy was measured by hits minus false alarms. | Posted | Mean | Standard Deviation | probability | 90 minutes into Session 2 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Adult Volunteers-Oral MDMA at Memory Encoding | 20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo. Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. Placebo |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Office of Clinical Research | University of Chicago | (773) 834-1238 | tkyeo@bsd.uchicago.edu |
Not provided
| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| BG001 | Healthy Adult Volunteers-Oral MDMA at Memory Retrievial | 20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later.. Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. Placebo |
| BG002 | Healthy Adult Volunteers-Placebo at Both Sessions | 20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later. Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Healthy Adult Volunteers-Oral MDMA at Memory Retrievial | 20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later.. Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. Placebo |
| OG002 | Healthy Adult Volunteers-Placebo at Both Sessions | 20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later. Placebo |
|
|
| Secondary | Probability of Accurately Recognizing Visual Stimuli | After the cued recollection task, all of the pictures were presented to participants (i.e., the ones that they had seen, as well as the ones that were not seen). Participants were then asked, "Did you see this picture?" Hit and false alarm rates were calculated, and memory accuracy was measured as hits minus false alarms. | Posted | Mean | Standard Deviation | probability | 90 minutes into Session 2 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Healthy Adult Volunteers-Oral MDMA at Memory Retrievial | 20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later.. Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. Placebo | 0 | 20 | 0 | 20 |
| EG002 | Healthy Adult Volunteers-Placebo at Both Sessions | 20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later. Placebo | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| Organic Chemicals |