Clinical trial NCT02630017: Motivated Behavior in Adults With and Without ADHD
Official title: Motivated Behavior in Adults With and Without ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ADHD
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: There are two parallel arms of this study (ADHD or non-ADHD subjects).

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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of High-effort Selections in the Effort-based Decision Making Task
timeFrame: 1 hour post drug (or placebo) administration for each study session
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: University of Arkansas
name: Merideth A Addicott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.