Healthy
Conditions
Keywords
MDMA, adult
Brief summary
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.
Detailed description
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.
Interventions
DRUGMDMA
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.
DRUGPlacebo
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal healthy males and females, aged 18-40 years.
Exclusion criteria
1. any current medical condition requiring medication or abnormal electrocardiogram 2. current or past medical condition considered to be a contraindication for the study conditions 3. any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis 4. less than high school education 5. lack of fluency in English 6. night shift work 7. pregnancy, lactation, or plans to become pregnant 8. use of hormonal contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of Accurately Recalling Visual Stimuli | 90 minutes into Session 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probability of Accurately Recognizing Visual Stimuli | 90 minutes into Session 2 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| 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 | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Healthy Adult Volunteers-Oral MDMA at Memory Encoding | Healthy Adult Volunteers-Oral MDMA at Memory Retrievial | Healthy Adult Volunteers-Placebo at Both Sessions | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 0 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 0 |
Outcome results
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.
Time frame: 90 minutes into Session 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Adult Volunteers-Oral MDMA at Memory Encoding | Probability of Accurately Recalling Visual Stimuli | .52 probability | Standard Deviation 0.11 |
| Healthy Adult Volunteers-Oral MDMA at Memory Retrievial | Probability of Accurately Recalling Visual Stimuli | .50 probability | Standard Deviation 0.16 |
| Healthy Adult Volunteers-Placebo at Both Sessions | Probability of Accurately Recalling Visual Stimuli | .54 probability | Standard Deviation 0.17 |
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.
Time frame: 90 minutes into Session 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Adult Volunteers-Oral MDMA at Memory Encoding | Probability of Accurately Recognizing Visual Stimuli | .82 probability | Standard Deviation 0.09 |
| Healthy Adult Volunteers-Oral MDMA at Memory Retrievial | Probability of Accurately Recognizing Visual Stimuli | .81 probability | Standard Deviation 0.15 |
| Healthy Adult Volunteers-Placebo at Both Sessions | Probability of Accurately Recognizing Visual Stimuli | .84 probability | Standard Deviation 0.11 |