- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02630017
Motivated Behavior in Adults With and Without ADHD (MOBE)
August 3, 2021 updated by: University of Arkansas
To investigate the effects of methylphenidate on motivated behavior in adults with and without ADHD
Study Overview
Status
Completed
Conditions
Detailed Description
This study has a mixed between- and within-subject design.
Participants are young adults (aged 18-45) with ADHD and non-ADHD matched controls.
They will be recruited from locations around the community, consented, screened for eligibility, then scheduled for 2 study days.
Study days will be at least 48 hours apart.
Thus, there will be a total of 3 lab visits across a 3 week period.
Participants will be administered study drug on one study day and placebo on the other study day.
They will complete a battery of cognitive/behavioral tasks and answer questionnaires on both study days.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- generally healthy
- between the ages of 18-45
- non-ADHD subjects do not meet criteria for ADHD diagnosis or any subtype as determined by the Conners Diagnostic Interview or any T-Score > 55 on Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index subscales of the CAARS.
- ADHD subjects meet criteria for a primary diagnosis of ADHD, any subtype, based on DSM-5
Exclusion Criteria:
- inability to attend all required experimental sessions
- significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
- primary diagnosis of Axis I psychiatric disorders other than ADHD (e.g., depression, anxiety disorder, schizophrenia)
- meet DSM-5 criteria for substance use disorder other than nicotine in the past 12 months
- use of psychoactive medications in the past 6 months as indicated by self-report
- positive urine drug screen for drugs or positive breath alcohol concentration
- contraindications for MPH
- among women, nursing or a positive pregnancy test
- IQ < 80 on Kaufman Brief Intelligence Test, 2nd edition
- allergy to lactose
- hypertension (If subject is ≤ 40 years of age and has blood pressure over 135/85 or heart rate over 90 beats per minute. If subject is > 40 years of age and has blood pressure over 130/80 or heart rate over 88 beats per minute)
- body mass ratio > 30
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADHD group
Adults with ADHD
|
double-blind, counter-balanced administration
double-blind, counter-balanced administration
|
Experimental: non-ADHD group
Adults without ADHD
|
double-blind, counter-balanced administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of High-effort Selections in the Effort-based Decision Making Task
Time Frame: 1 hour post drug (or placebo) administration for each study session
|
Number of high-effort selections in the effort-based decision making task from the placebo to the methylphenidate condition.
This is a decision-making task where participants make high- or low-effort choices to earn a small financial reward.
High-effort selections require 100 button presses with non-dominant hand pinky finger and low-effort selections require 30 button presses with dominant hand index finger (within 15 seconds).
The number of high effort selections are summed across 50 trials of the task.
This task measures the willingness to perform effort in relation to changing reward magnitude and probability.
This is a basic science experiment, the clinical and/or physiological relevance of these results are not established.
|
1 hour post drug (or placebo) administration for each study session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merideth A Addicott, PhD, University of Arkansas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2016
Primary Completion (Actual)
September 21, 2018
Study Completion (Actual)
September 21, 2018
Study Registration Dates
First Submitted
December 8, 2015
First Submitted That Met QC Criteria
December 10, 2015
First Posted (Estimate)
December 15, 2015
Study Record Updates
Last Update Posted (Actual)
August 27, 2021
Last Update Submitted That Met QC Criteria
August 3, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 207259
- Pro00068353 (Other Identifier: Duke University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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