Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2016-03-07
2018-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
Within each arm, each subject will be exposed to placebo and a drug (each at a different timepoint in the study). Although all subjects will receive both placebo and the drug, the order of presentation of the placebo and drug is counterbalanced across subjects (i.e., approximately half will receive the drug first and approximately half will receive the placebo first).
For both study arms, regardless of whether the placebo is received first or second, the outcome measure will be calculated as the number of high effort selections.
BASIC_SCIENCE
DOUBLE
Study Groups
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ADHD group
Adults with ADHD
ADHD methylphenidate first, placebo second
double-blind, counter-balanced administration
ADHD placebo first, methylphenidate second
double-blind, counter-balanced administration
non-ADHD group
Adults without ADHD
Non-ADHD methylphenidate first, placebo second
double-blind, counter-balanced administration
Non-ADHD placebo first, methylphenidate second
Interventions
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ADHD methylphenidate first, placebo second
double-blind, counter-balanced administration
ADHD placebo first, methylphenidate second
double-blind, counter-balanced administration
Non-ADHD methylphenidate first, placebo second
double-blind, counter-balanced administration
Non-ADHD placebo first, methylphenidate second
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
ALL
Yes
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Merideth A Addicott, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Duke University
Durham, North Carolina, United States
Countries
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References
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Addicott MA, Schechter JC, Sapyta JJ, Selig JP, Kollins SH, Weiss MD. Methylphenidate increases willingness to perform effort in adults with ADHD. Pharmacol Biochem Behav. 2019 Aug;183:14-21. doi: 10.1016/j.pbb.2019.06.008. Epub 2019 Jun 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Pro00068353
Identifier Type: OTHER
Identifier Source: secondary_id
207259
Identifier Type: -
Identifier Source: org_study_id
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