Stimulant Medication for ADHD

Overseen By Cynthia M Hartung, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wyoming

Must not be taking: SSRIs, SNRIs, Sedatives, others

Disqualifiers: Seizure disorder, Bipolar, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Adderall, a common ADHD medication, affects thinking skills such as attention and memory in college students. Researchers aim to determine whether Adderall improves these skills in students diagnosed with ADHD and confirm that it does not have the same effect on those without ADHD. The results could guide proper stimulant use and discourage misuse among students. College students with an ADHD diagnosis or those without any ADHD history who are interested in participating should be able to take Adderall safely and be currently enrolled in college. As a Phase 2 trial, this research measures how well Adderall works in an initial, smaller group of people, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

If you are currently taking a prescription stimulant for ADHD, you will need to stop taking it the day before and the day of any study visits. Additionally, you cannot participate if you are using other psychotropic drugs or certain medications that could interact with Adderall.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study tested Adderall IR (immediate release) 10mg in people with ADHD. The results showed that participants generally tolerated the medication well. Most side effects were mild, such as trouble sleeping and loss of appetite, which are common with stimulant medications.

Another review of amphetamine-based treatments, like Adderall, found that they are safe for many people. However, some may experience more serious side effects, such as increased heart rate or blood pressure. These effects occur more frequently with higher doses, but it's important to monitor for them even at lower doses like 10mg.

While past studies provide some safety information, personal experiences can vary. Always consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ADHD?

Most treatments for ADHD, like Adderall, Ritalin, and Vyvanse, are stimulants that work by increasing the levels of certain neurotransmitters in the brain, specifically dopamine and norepinephrine. The study treatment, Adderall IR 10mg, is unique because it uses an immediate-release formulation that can offer quick relief from ADHD symptoms. Researchers are excited about this treatment as it provides the potential for more precise control over dosing and timing, which can help in managing symptoms more effectively throughout the day. This is different from extended-release versions, which release medication gradually and may not offer the same level of immediate symptom control.

What evidence suggests that this treatment might be an effective treatment for ADHD?

Research has shown that medications like Adderall can help treat ADHD. One study found that Adderall improved focus and reduced impulsive behavior in children with ADHD. These changes suggest that the medication aids in skills like staying focused and managing tasks. This trial will administer Adderall IR 10mg to participants to evaluate its effects on sustained attention and working memory. However, for students without ADHD, these medications usually do not improve focus or task management and can be misused. Overall, stimulants like Adderall effectively manage ADHD symptoms, but their benefits are specific to those diagnosed with the condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Cynthia M Hartung, Ph.D.

Principal Investigator

University of Wyoming

Are You a Good Fit for This Trial?

This trial is for college students aged 18-29 with ADHD who have been previously diagnosed and report significant inattention symptoms. They must be native English speakers, not pregnant, non-smokers, and not using conflicting medications or substances. Healthy peers without ADHD are also included as controls if they match an ADHD participant's age and sex.

Inclusion Criteria

Be between the ages of 18-29

You have been diagnosed with ADHD and experience five or more symptoms of inattention according to the DSM-5 Symptom Checklist.

If you are a healthy participant, you must not have been diagnosed with ADHD and should have very few symptoms of inattention and hyperactivity/impulsivity.

Exclusion Criteria

Participants will be excluded if they are pregnant (determined by a urine pregnancy test), are attempting to become pregnant, or are currently breastfeeding

Not meeting any of the above stated inclusion criteria

Any contraindications for physical exercise placing the participant at moderate or high-risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants attend a baseline appointment to confirm eligibility and complete baseline measures

1 week

1 visit (in-person)

Experimental Appointments

Participants attend two experimental appointments where they receive either a placebo or stimulant and complete cognitive tests

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Remote follow-up via questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Adderall IR 10mg
• Placebo

Trial Overview The study tests the immediate effects of Adderall IR (a stimulant medication) on executive functioning in college students with ADHD compared to a placebo. The goal is to see if Adderall improves attention and working memory better than no treatment at all.

How Is the Trial Designed?

Group I: Stimulant Medication Experimental Treatment 2 Interventions

Participants will be administered a stimulant medication (Adderall IR 10mg). The ordering of experimental vs. placebo appointments will be counterbalanced. Participants will complete computer-based tests of sustained attention and working memory during all appointments.

Adderall IR 10mg is already approved in United States, Canada for the following indications:

Approved in United States as Adderall for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Approved in Canada as Adderall for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Who Is Running the Clinical Trial?

University of Wyoming

Lead Sponsor

Trials

20

Recruited

1,600+

Published Research Related to This Trial

Adderall XR is a long-acting psychostimulant approved for treating ADHD in both children and adults, with a 12-hour duration of action and demonstrated superior efficacy compared to the nonstimulant atomoxetine.

The largest effectiveness trial for ADHD therapies confirmed that Adderall XR significantly improves quality of life in children and shows proven safety and efficacy in adults, with potential benefits for treating comorbid conditions like oppositional defiant disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adderall XR: long acting stimulant for single daily dosing. Sallee, FR., Smirnoff, AV.[2019]

Combination therapy using stimulants and atomoxetine may improve ADHD symptoms in some patients, particularly children and adolescents with the combined subtype, but results vary widely among individuals.

The review highlighted that there were no serious adverse events reported, suggesting that this combination therapy is generally safe, although the evidence is limited and based on a small number of studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of combination therapy with stimulants and atomoxetine for attention-deficit/hyperactivity disorder, including patient characteristics, treatment strategies, effectiveness, and tolerability. Treuer, T., Gau, SS., Méndez, L., et al.[2021]

SLI381 (Adderall-XR) has been shown to be a safe and effective treatment for ADHD in over 500 patients, with therapeutic effects lasting up to 12 hours, particularly at higher doses.

The side effects of SLI381 are similar to those of the existing Adderall preparation, with no significant increase in incidence except for anorexia, making it a reliable once-daily dosing option for ADHD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SLI381: a long-acting psychostimulant preparation for the treatment of attention-deficit hyperactivity disorder. Grcevich, S.[2019]

Serdexmethylphenidate (SDX) is a newly approved treatment for ADHD that offers a longer duration of action compared to other stimulant medications, making it a promising option for patients.

Early studies indicate that SDX is safe and has side effects similar to other stimulants, while its prodrug design may help reduce the risk of abuse and allows for flexible administration for those who have difficulty swallowing pills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating serdexmethylphenidate and dexmethylphenidate capsules as a once-daily treatment option for ADHD. Barnhardt, EA., Narayanan, AR., Coury, DL.[2023]

SLI381 (Adderall XR) demonstrated significant, dose-related improvements in ADHD symptoms in children aged 6 to 12 years, with consistent efficacy observed throughout the day, as measured by both teachers and parents.

The study, involving 584 children in a randomized, double-blind trial, showed that SLI381 was well-tolerated with a low incidence of adverse events, indicating it is a safe and effective once-daily treatment for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorder. Biederman, J., Lopez, FA., Boellner, SW., et al.[2019]

A study involving 32 healthy adults found that coingestion of varying concentrations of alcohol (4%-40%) did not significantly affect the absorption or pharmacokinetics of the ADHD medication Adzenys™ XR-ODT (amphetamine).

The safety profile was consistent with known effects of amphetamine and alcohol, indicating that the combination does not lead to dose dumping or altered drug effectiveness, which is important for clinicians treating ADHD patients who may also consume alcohol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase I Study to Assess the Effect of Alcohol on the Pharmacokinetics of an Extended-release Orally Disintegrating Tablet Formulation of Amphetamine in Healthy Adults. Newcorn, JH., Stark, JG., Adcock, S., et al.[2018]

The study demonstrated that AMP XR-OS, a new extended-release amphetamine oral suspension, is bioequivalent to Adderall XR, as shown by pharmacokinetic parameters in 42 healthy adult volunteers.

Safety monitoring revealed that the most common side effects were nausea and decreased appetite, indicating that AMP XR-OS has a similar safety profile to Adderall XR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults. Sikes, C., Stark, JG., McMahen, R., et al.[2022]

A study using pharmacological MRI in rats showed that D- and L-amphetamine isomers produce different blood-oxygen-level-dependent (BOLD) responses in brain regions associated with cognition and motor control, suggesting they may have distinct effects on brain function.

The L-isomer of amphetamine resulted in greater overall changes in brain activity compared to the D-isomer, particularly in areas like the somatosensory and motor cortices, which could influence treatment strategies for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of the D- and L- isomers of amphetamine on pharmacological MRI BOLD contrast in the rat. Easton, N., Marshall, F., Fone, KC., et al.[2022]

Citations

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Practice Pearls for Stimulant Treatment of Attention-Deficit ... This manuscript presents evidence-based practice pearls to guide treatment decisions for youth with ADHD and common coexisting psychiatric and medical ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/14737175.2024.2321921

A review of amphetamine extended release once-daily ... A randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (adderall XR) in children with attention-deficit/hyperactivity ...

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Compare Dyanavel XR vs. Adderall XR Compare Dyanavel XR and Adderall XR side effects, costs and risks for treating ADHD.

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06446-z

Extended-release amphetamine (Dyanavel XR) is associated ... Dyanavel XR was significantly associated with reduced IR supplementation at 90 days compared to the pooled group of patients taking other ER medications.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8412159/

Novel Formulations of ADHD Medications: Stimulant ... : Treatment of children with attention-deficit/hyperactivity disorder: results of a randomized, multicenter, double-blind, crossover study ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/amphetamine-oral-route/description/drg-20150941

Amphetamine (oral route) - Side effects & dosage Safety and efficacy have not been established. Appropriate studies have not been performed on the relationship of age to the effects of ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/204326s011lbl.pdf

Adzenys XR-ODT - accessdata.fda.gov Improvements, measured with the Attention Deficit Hyperactivity. Disorder-Rating Scale (ADHD-RS) were observed at endpoint for MAS ER 20, 40 and 60 mg, compared ...