Trial Outcomes & Findings for Effects of MDMA on Emotional and Social Memories (NCT NCT03050541)
NCT ID: NCT03050541
Last Updated: 2018-06-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
90 minutes into Session 2
Results posted on
2018-06-29
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
28
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of MDMA on Emotional and Social Memories
Baseline characteristics by cohort
| Measure |
Healthy Adult Volunteers-Oral MDMA at Memory Encoding
n=20 Participants
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
|
Healthy Adult Volunteers-Oral MDMA at Memory Retrievial
n=20 Participants
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
|
Healthy Adult Volunteers-Placebo at Both Sessions
n=20 Participants
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
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 90 minutes into Session 2During 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.
Outcome measures
| Measure |
Healthy Adult Volunteers-Oral MDMA at Memory Encoding
n=20 Participants
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
|
Healthy Adult Volunteers-Oral MDMA at Memory Retrievial
n=20 Participants
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
|
Healthy Adult Volunteers-Placebo at Both Sessions
n=20 Participants
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
|
|---|---|---|---|
|
Probability of Accurately Recalling Visual Stimuli
|
.52 probability
Standard Deviation .11
|
.50 probability
Standard Deviation .16
|
.54 probability
Standard Deviation .17
|
SECONDARY outcome
Timeframe: 90 minutes into Session 2After 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.
Outcome measures
| Measure |
Healthy Adult Volunteers-Oral MDMA at Memory Encoding
n=20 Participants
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
|
Healthy Adult Volunteers-Oral MDMA at Memory Retrievial
n=20 Participants
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
|
Healthy Adult Volunteers-Placebo at Both Sessions
n=20 Participants
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
|
|---|---|---|---|
|
Probability of Accurately Recognizing Visual Stimuli
|
.82 probability
Standard Deviation .09
|
.81 probability
Standard Deviation .15
|
.84 probability
Standard Deviation .11
|
Adverse Events
Healthy Adult Volunteers-Oral MDMA at Memory Encoding
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Adult Volunteers-Oral MDMA at Memory Retrievial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Adult Volunteers-Placebo at Both Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place