Trial Outcomes & Findings for Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS)) (NCT NCT01993108)
NCT ID: NCT01993108
Last Updated: 2018-06-18
Results Overview
Multi-Source Interference Task is a psychological task that measures the psychological construct of cognitive control, the ability to suppress automatic response tendencies. Reaction time variability is the standard deviation of the trial to trial reaction time measured in seconds.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
2 hours
Results posted on
2018-06-18
Participant Flow
Participant milestones
| Measure |
Healthy Controls
Healthy individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.
Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning.
Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning.
Placebo: One dose of placebo one hour before fMRI scanning.
|
Adult Attention-Deficit/Hyperactivity Disorder
ADHD individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.
Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning.
Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning.
Placebo: One dose of placebo one hour before fMRI scanning.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=11 Participants
Healthy individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.
Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning.
Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning.
Placebo: One dose of placebo one hour before fMRI scanning.
|
Adult Attention-Deficit/Hyperactivity Disorder
n=12 Participants
ADHD individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.
Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning.
Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning.
Placebo: One dose of placebo one hour before fMRI scanning.
|
Total
n=23 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
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.9 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
22.08 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
23.4 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursMulti-Source Interference Task is a psychological task that measures the psychological construct of cognitive control, the ability to suppress automatic response tendencies. Reaction time variability is the standard deviation of the trial to trial reaction time measured in seconds.
Outcome measures
| Measure |
Methlyphenidate in Healthy Controls
n=11 Participants
40mg methylphenidate in Healthy Controls
|
Naltrexone in Healthy Controls
n=11 Participants
40mg Naltrexone in Healthy Controls
|
Placebo in Healthy Controls
n=11 Participants
Placebo Pill in Healthy Controls
|
Methlyphenidate in ADHD
n=12 Participants
40mg methylphenidate in ADHD
|
Naltrexone in ADHD
n=12 Participants
40mg naltrexone in ADHD
|
Placebo in ADHD
n=12 Participants
Placebo Pill in ADHD
|
|---|---|---|---|---|---|---|
|
Reaction Time Variability on the Multi-Source Interference Task
|
.22 seconds
Standard Deviation .07
|
.23 seconds
Standard Deviation .06
|
.26 seconds
Standard Deviation .06
|
.20 seconds
Standard Deviation .06
|
.20 seconds
Standard Deviation .05
|
.21 seconds
Standard Deviation .06
|
SECONDARY outcome
Timeframe: Two hoursReaction time of the Multi-Source Interference Task is measured in seconds.
Outcome measures
| Measure |
Methlyphenidate in Healthy Controls
n=11 Participants
40mg methylphenidate in Healthy Controls
|
Naltrexone in Healthy Controls
n=11 Participants
40mg Naltrexone in Healthy Controls
|
Placebo in Healthy Controls
n=11 Participants
Placebo Pill in Healthy Controls
|
Methlyphenidate in ADHD
n=12 Participants
40mg methylphenidate in ADHD
|
Naltrexone in ADHD
n=12 Participants
40mg naltrexone in ADHD
|
Placebo in ADHD
n=12 Participants
Placebo Pill in ADHD
|
|---|---|---|---|---|---|---|
|
Reaction Time on the Multi-Source Interference Task
|
.78 seconds
Standard Deviation .12
|
.83 seconds
Standard Deviation .10
|
.85 seconds
Standard Deviation .14
|
.71 seconds
Standard Deviation .10
|
.73 seconds
Standard Deviation .09
|
.77 seconds
Standard Deviation .10
|
SECONDARY outcome
Timeframe: Two hoursAccuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task.
Outcome measures
| Measure |
Methlyphenidate in Healthy Controls
n=11 Participants
40mg methylphenidate in Healthy Controls
|
Naltrexone in Healthy Controls
n=11 Participants
40mg Naltrexone in Healthy Controls
|
Placebo in Healthy Controls
n=11 Participants
Placebo Pill in Healthy Controls
|
Methlyphenidate in ADHD
n=12 Participants
40mg methylphenidate in ADHD
|
Naltrexone in ADHD
n=12 Participants
40mg naltrexone in ADHD
|
Placebo in ADHD
n=12 Participants
Placebo Pill in ADHD
|
|---|---|---|---|---|---|---|
|
Accuracy on the Multi-Source Interference Task
|
96 percent of total trials
Standard Deviation 2
|
93 percent of total trials
Standard Deviation 7
|
91 percent of total trials
Standard Deviation 8
|
93 percent of total trials
Standard Deviation 10
|
93 percent of total trials
Standard Deviation 8
|
92 percent of total trials
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Two hoursThe effects of methylphenidate, naltrexone, and placebo on the change in BOLD (Blood Oxygen Level Dependent) signal will be characterized in the incongruent condition (cognitive regulation condition) of the MSIT (multi-source interference task) relative to the congruent condition (no regulation condition). Specifically, the summed BOLD signal in three regions--dorsal lateral prefrontal cortex, anterior insula, anterior cingulate--are measured.
Outcome measures
| Measure |
Methlyphenidate in Healthy Controls
n=11 Participants
40mg methylphenidate in Healthy Controls
|
Naltrexone in Healthy Controls
n=11 Participants
40mg Naltrexone in Healthy Controls
|
Placebo in Healthy Controls
n=11 Participants
Placebo Pill in Healthy Controls
|
Methlyphenidate in ADHD
n=12 Participants
40mg methylphenidate in ADHD
|
Naltrexone in ADHD
n=12 Participants
40mg naltrexone in ADHD
|
Placebo in ADHD
n=12 Participants
Placebo Pill in ADHD
|
|---|---|---|---|---|---|---|
|
Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.
|
.21 Mean percentage of BOLD signal change
Standard Deviation .51
|
.51 Mean percentage of BOLD signal change
Standard Deviation .58
|
.20 Mean percentage of BOLD signal change
Standard Deviation .45
|
.43 Mean percentage of BOLD signal change
Standard Deviation .40
|
.58 Mean percentage of BOLD signal change
Standard Deviation .59
|
.47 Mean percentage of BOLD signal change
Standard Deviation .56
|
Adverse Events
Methlyphenidate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naltrexone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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