ADHDPhase 2MOBENCT02630017
Motivated Behavior in Adults With and Without ADHD
A Phase 2 study of ADHD, run by University of Arkansas at 2 sites in United States.
Trial summary
To investigate the effects of methylphenidate on motivated behavior in adults with and without ADHD Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2016to 21 Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- generally healthy
- between the ages of 18-45
- 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.
- ADHD subjects meet criteria for a primary diagnosis of ADHD, any subtype, based on DSM-5
Who cannot join
- inability to attend all required experimental sessions
- significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
- primary diagnosis of Axis I psychiatric disorders other than ADHD (e.g., depression, anxiety disorder, schizophrenia)
- meet DSM-5 criteria for substance use disorder other than nicotine in the past 12 months
- use of psychoactive medications in the past 6 months as indicated by self-report
- positive urine drug screen for drugs or positive breath alcohol concentration
Show all 12Show fewer
- contraindications for MPH
- among women, nursing or a positive pregnancy test
- IQ < 80 on Kaufman Brief Intelligence Test, 2nd edition
- allergy to lactose
- 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)
- body mass ratio > 30
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27705
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
To investigate the effects of methylphenidate on motivated behavior in adults with and without ADHD
Read the 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.
- Conditions
- ADHD
- Being tested
- ADHD methylphenidate first, placebo second, ADHD placebo first, methylphenidate second, Non-ADHD methylphenidate first, placebo second, Non-ADHD placebo first, methylphenidate second
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHD methylphenidate first, placebo secondDrug
double-blind, counter-balanced administration
ADHD placebo first, methylphenidate secondDrug
double-blind, counter-balanced administration
Non-ADHD methylphenidate first, placebo secondDrug
double-blind, counter-balanced administration
Non-ADHD placebo first, methylphenidate secondDrug
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Experimental | Adults with ADHD Receives: Drug: ADHD methylphenidate first, placebo second; Drug: ADHD placebo first, methylphenidate second |
| non-ADHD group | Experimental | Adults without ADHD Receives: Drug: Non-ADHD methylphenidate first, placebo second; Drug: Non-ADHD placebo first, methylphenidate second |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of High-effort Selections in the Effort-based Decision Making Task
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.
Measured: 1 hour post drug (or placebo) administration for each study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start7 Mar 2016
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merideth A Addicott, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630017
- Sponsor's protocol ID
- 207259
- Other IDs
- Pro00068353
- Acronym
- MOBE
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2015
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31226260
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivated Behavior in Adults With and Without ADHD
- ClinicalTrials.gov ID
- NCT02630017
- Acronym / sponsor ID
- MOBE / 207259
- Conditions
- ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Posted 27 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ADHD group | Experimental | Drug: ADHD methylphenidate first, placebo second, Drug: ADHD placebo first, methylphenidate secondAdults with ADHD |
| non-ADHD group | Experimental | Drug: Non-ADHD methylphenidate first, placebo second, Drug: Non-ADHD placebo first, methylphenidate secondAdults without ADHD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- generally healthy
- between the ages of 18-45
- 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.
- ADHD subjects meet criteria for a primary diagnosis of ADHD, any subtype, based on DSM-5
Key exclusion criteria (12 listed)
- inability to attend all required experimental sessions
- significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
- primary diagnosis of Axis I psychiatric disorders other than ADHD (e.g., depression, anxiety disorder, schizophrenia)
- meet DSM-5 criteria for substance use disorder other than nicotine in the past 12 months
- use of psychoactive medications in the past 6 months as indicated by self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHD methylphenidate first, placebo seconddouble-blind, counter-balanced administration | Drug | ADHD group |
| ADHD placebo first, methylphenidate seconddouble-blind, counter-balanced administration | Drug | ADHD group |
| Non-ADHD methylphenidate first, placebo seconddouble-blind, counter-balanced administration | Drug | non-ADHD group |
| Non-ADHD placebo first, methylphenidate second | Drug | non-ADHD group |
Primary outcome
Number of High-effort Selections in the Effort-based Decision Making Task
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31226260Addicott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merideth A Addicott, PhD principal investigator
University of Arkansas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of ADHD, run by University of Arkansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of High-effort Selections in the Effort-based Decision Making Task (time frame: 1 hour post drug (or placebo) administration for each study session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.