Trial Outcomes & Findings for Effect of Stimulant Drugs on Social Perception (NCT NCT03790618)
NCT ID: NCT03790618
Last Updated: 2024-01-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
End of study (time 0 and approximately six weeks later)
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Stimulant Drugs on Social Perception
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
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.
|
Low Dose MDMA
n=9 Participants
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.
|
High Dose MDMA
n=9 Participants
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.
|
Methamphetamine
n=9 Participants
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.
|
Total
n=36 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Education - High School Education
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: End of study (time 0 and approximately six weeks later)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
Outcome measures
| Measure |
Placebo
n=9 Participants
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.
|
Low Dose MDMA
n=9 Participants
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.
|
High Dose MDMA
n=9 Participants
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.
|
Methamphetamine
n=9 Participants
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.
|
|---|---|---|---|---|
|
Responses to Affective Touch
|
-1.24 units on a scale
Standard Deviation 3.22
|
0.12 units on a scale
Standard Deviation 3.14
|
0.19 units on a scale
Standard Deviation 2.25
|
0.25 units on a scale
Standard Deviation 2.68
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose MDMA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose MDMA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methamphetamine
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