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Trial record 51 of 439 for:    Methylphenidate

Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS)) (NMAS)

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ClinicalTrials.gov Identifier: NCT01993108
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chandra Sekhar Sripada, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Conditions Healthy
Attention Deficit Hyperactivity Disorder
Interventions Drug: Methylphenidate
Drug: Naltrexone
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Controls Adult Attention-Deficit/Hyperactivity Disorder
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 11 12
Completed 11 12
Not Completed 0 0
Arm/Group Title Healthy Controls Adult Attention-Deficit/Hyperactivity Disorder Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
12
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 23 participants
24.9  (5.0) 22.08  (3.4) 23.4  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
8
  72.7%
7
  58.3%
15
  65.2%
Male
3
  27.3%
5
  41.7%
8
  34.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  18.2%
2
  16.7%
4
  17.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   9.1%
2
  16.7%
3
  13.0%
White
7
  63.6%
8
  66.7%
15
  65.2%
More than one race
1
   9.1%
0
   0.0%
1
   4.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants 12 participants 23 participants
11
 100.0%
12
 100.0%
23
 100.0%
1.Primary Outcome
Title Reaction Time Variability on the Multi-Source Interference Task
Hide Description 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.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methlyphenidate in Healthy Controls Naltrexone in Healthy Controls Placebo in Healthy Controls Methlyphenidate in ADHD Naltrexone in ADHD Placebo in ADHD
Hide Arm/Group Description:
40mg methylphenidate in Healthy Controls
40mg Naltrexone in Healthy Controls
Placebo Pill in Healthy Controls
40mg methylphenidate in ADHD
40mg naltrexone in ADHD
Placebo Pill in ADHD
Overall Number of Participants Analyzed 11 11 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: seconds
.22  (.07) .23  (.06) .26  (.06) .20  (.06) .20  (.05) .21  (.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methlyphenidate in Healthy Controls, Placebo in Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Naltrexone in Healthy Controls, Placebo in Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .118
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Methlyphenidate in ADHD, Placebo in ADHD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .349
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value .02
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Naltrexone in ADHD, Placebo in ADHD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .348
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value .02
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Reaction Time on the Multi-Source Interference Task
Hide Description Reaction time of the Multi-Source Interference Task is measured in seconds.
Time Frame Two hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methlyphenidate in Healthy Controls Naltrexone in Healthy Controls Placebo in Healthy Controls Methlyphenidate in ADHD Naltrexone in ADHD Placebo in ADHD
Hide Arm/Group Description:
40mg methylphenidate in healthy controls
40mg Naltrexone in healthy controls
Placebo pill in healthy controls
40mg methylphenidate in ADHD
40mg naltrexone in ADHD
placebo pill in ADHD
Overall Number of Participants Analyzed 11 11 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: seconds
.78  (.12) .83  (.10) .85  (.14) .71  (.10) .73  (.09) .77  (.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methlyphenidate in Healthy Controls, Placebo in Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .019
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Naltrexone in Healthy Controls, Placebo in Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .240
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Methlyphenidate in ADHD, Placebo in ADHD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .081
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value .06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Naltrexone in ADHD, Placebo in ADHD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .247
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value .04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Accuracy on the Multi-Source Interference Task
Hide Description Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task.
Time Frame Two hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methlyphenidate in Healthy Controls Naltrexone in Healthy Controls Placebo in Healthy Controls Methlyphenidate in ADHD Naltrexone in ADHD Placebo in ADHD
Hide Arm/Group Description:
40mg methylphenidate in Healthy Controls
40mg Naltrexone in Healthy Controls
Placebo pill in Healthy Controls
40mg methlyphenidate in ADHD
40mg naltrexone in ADHD
Placebo pill in ADHD
Overall Number of Participants Analyzed 11 11 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: percent of total trials
96  (2) 93  (7) 91  (8) 93  (10) 93  (8) 92  (5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methlyphenidate in Healthy Controls, Placebo in Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .049
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Naltrexone in Healthy Controls, Placebo in Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .497
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Methlyphenidate in ADHD, Placebo in ADHD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .814
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Naltrexone in ADHD, Placebo in ADHD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .593
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .01
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.
Hide Description The 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.
Time Frame Two hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methlyphenidate in Healthy Controls Naltrexone in Healthy Controls Placebo in Healthy Controls Methlyphenidate in ADHD Naltrexone in ADHD Placebo in ADHD
Hide Arm/Group Description:
40mg methylphenidate in Healthy Controls
40mg Naltrexone in Healthy Controls
Placebo pill in Healthy Controls
40mg methlyphenidate in ADHD
40mg naltrexone in ADHD
Placebo pill in ADHD
Overall Number of Participants Analyzed 11 11 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: Mean percentage of BOLD signal change
.21  (.51) .51  (.58) .20  (.45) .43  (.40) .58  (.59) .47  (.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methlyphenidate in Healthy Controls, Placebo in Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .926
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Naltrexone in Healthy Controls, Placebo in Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .126
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Methlyphenidate in ADHD, Placebo in ADHD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .852
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .04
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Naltrexone in ADHD, Placebo in ADHD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .552
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value .11
Estimation Comments [Not Specified]
Time Frame Subjects were observed for 2.5 to 3 hours during the course of each of the three scanning sessions.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methlyphenidate Naltrexone Placebo
Hide Arm/Group Description 40mg methylphenidate 40mg Naltrexone Placebo
All-Cause Mortality
Methlyphenidate Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Methlyphenidate Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methlyphenidate Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chandra Sripada
Organization: University of Michigan
Phone: 734 232 0281
EMail: sripada@umich.edu
Layout table for additonal information
Responsible Party: Chandra Sekhar Sripada, University of Michigan
ClinicalTrials.gov Identifier: NCT01993108     History of Changes
Other Study ID Numbers: HUM00047129
First Submitted: November 13, 2013
First Posted: November 25, 2013
Results First Submitted: March 20, 2018
Results First Posted: June 18, 2018
Last Update Posted: June 18, 2018