Motivated Behavior in Adults With and Without ADHD

NCT ID: NCT02630017

Last Updated: 2021-08-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-07

Study Completion Date

2018-09-21

Brief Summary

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

Detailed Description

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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.

Conditions

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ADHD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ADHD group

Adults with ADHD

Group Type EXPERIMENTAL

ADHD methylphenidate first, placebo second

Intervention Type DRUG

double-blind, counter-balanced administration

ADHD placebo first, methylphenidate second

Intervention Type DRUG

double-blind, counter-balanced administration

non-ADHD group

Adults without ADHD

Group Type EXPERIMENTAL

Non-ADHD methylphenidate first, placebo second

Intervention Type DRUG

double-blind, counter-balanced administration

Non-ADHD placebo first, methylphenidate second

Intervention Type DRUG

Interventions

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ADHD methylphenidate first, placebo second

double-blind, counter-balanced administration

Intervention Type DRUG

ADHD placebo first, methylphenidate second

double-blind, counter-balanced administration

Intervention Type DRUG

Non-ADHD methylphenidate first, placebo second

double-blind, counter-balanced administration

Intervention Type DRUG

Non-ADHD placebo first, methylphenidate second

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 31226260 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

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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