Trial Outcomes & Findings for Effects of Drugs on Responses to Brain and Emotional Processes (NCT NCT04053036)
NCT ID: NCT04053036
Last Updated: 2024-11-25
Results Overview
Participants will complete an affective touch task during which time they will rate pleasantness of touch on a scale of -10 to +10 using an analog scale. Higher ratings indicate greater pleasantness.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
22 participants
Primary outcome timeframe
1.5 hrs after drug or placebo administration.
Results posted on
2024-11-25
Participant Flow
Participant milestones
| Measure |
Placebo Then MDMA
Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive MDMA (1.5 mg/kg)
MDMA: Participants will be given 1.5mg/kg of MDMA
Placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.
|
MDMA Then Placebo
Participants first receive MDMA (1.5 mg/kg) at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo.
MDMA: Participants will be given 1.5mg/kg of MDMA
Placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Drugs on Responses to Brain and Emotional Processes
Baseline characteristics by cohort
| Measure |
Placebo Then MDMA
n=11 Participants
Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive MDMA (1.5 mg/kg)
MDMA: Participants will be given 1.5mg/kg of MDMA
Placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.
|
MDMA Then Placebo
n=11 Participants
Participants first receive MDMA (1.5 mg/kg) at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo.
MDMA: Participants will be given 1.5mg/kg of MDMA
Placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.
|
Total
n=22 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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
High School Education
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5 hrs after drug or placebo administration.Participants will complete an affective touch task during which time they will rate pleasantness of touch on a scale of -10 to +10 using an analog scale. Higher ratings indicate greater pleasantness.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo oral tablet: Participants were given a placebo capsule that only contained lactose.
|
MDMA
n=22 Participants
Participants first received MDMA (1.5 mg/kg) in a capsule
|
|---|---|---|
|
Change in Responses to Affective Touch
|
3.01 units on a scale
Standard Deviation .7
|
4.06 units on a scale
Standard Deviation .5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MDMA
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