Motivated Behavior in Adults With and Without ADHD (MOBE)

University of Arkansas

Status and phase: Completed; Phase 2

Conditions: ADHD

Treatments: Drug: ADHD placebo first, methylphenidate second; Drug: Non-ADHD methylphenidate first, placebo second; Drug: ADHD methylphenidate first, placebo second; Drug: Non-ADHD placebo first, methylphenidate second

Study type: Interventional

Funder types: Other

Identifiers

NCT02630017

207259

Pro00068353 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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51 participants in 2 patient groups

ADHD group

Experimental group

Description:

Adults with ADHD

Treatment:

Drug: ADHD methylphenidate first, placebo second

Drug: ADHD placebo first, methylphenidate second

non-ADHD group

Experimental group

Description:

Adults without ADHD

Treatment:

Drug: Non-ADHD methylphenidate first, placebo second

Drug: Non-ADHD placebo first, methylphenidate second