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Completed

NCT Number: NCT02630017

Motivated Behavior in Adults With and Without ADHD

To investigate the effects of methylphenidate on motivated behavior in adults with and without ADHD

Completed

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADHD methylphenidate first, placebo second

Drug

double-blind, counter-balanced administration

ADHD placebo first, methylphenidate second

Drug

double-blind, counter-balanced administration

Non-ADHD methylphenidate first, placebo second

Drug

double-blind, counter-balanced administration

Non-ADHD placebo first, methylphenidate second

Drug

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Acronym: MOBE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2015
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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