Motivated Behavior in Adults With and Without ADHD

Phase 2

Completed

• Conditions: ADHD
• Interventions: Drug: ADHD methylphenidate first, placebo second; Drug: Non-ADHD methylphenidate first, placebo second; Drug: ADHD placebo first, methylphenidate second; Drug: Non-ADHD placebo first, methylphenidate second

• Registration Number: NCT02630017
• Lead Sponsor: University of Arkansas

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-15
• Study Start: 2016-03-07
• Primary Completion: 2018-09-21
• Study Completion: 2018-09-21
• Results First Submitted: 2021-04-23
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Results First Posted: 2021-08-27
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. generally healthy
2. between the ages of 18-45
3. 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.
4. ADHD subjects meet criteria for a primary diagnosis of ADHD, any subtype, based on DSM-5

Exclusion Criteria

1. inability to attend all required experimental sessions
2. significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
3. primary diagnosis of Axis I psychiatric disorders other than ADHD (e.g., depression, anxiety disorder, schizophrenia)
4. meet DSM-5 criteria for substance use disorder other than nicotine in the past 12 months
5. use of psychoactive medications in the past 6 months as indicated by self-report
6. positive urine drug screen for drugs or positive breath alcohol concentration
7. contraindications for MPH
8. among women, nursing or a positive pregnancy test
9. IQ < 80 on Kaufman Brief Intelligence Test, 2nd edition
10. allergy to lactose
11. 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)
12. body mass ratio > 30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ADHD group	ADHD methylphenidate first, placebo second	Adults with ADHD
ADHD group	ADHD placebo first, methylphenidate second	Adults with ADHD
non-ADHD group	Non-ADHD methylphenidate first, placebo second	Adults without ADHD
non-ADHD group	Non-ADHD placebo first, methylphenidate second	Adults without ADHD

Primary Outcome Measures

Name	Time	Method
Number of High-effort Selections in the Effort-based Decision Making Task	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.

Trial Locations

Locations (2)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Duke University; 🇺🇸 Durham, North Carolina, United States