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Central Nervous System Stimulant
Stimulant Medication for ADHD
Phase 2
Recruiting
Led By Cynthia M Hartung, Ph.D.
Research Sponsored by University of Wyoming
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two weeks
Awards & highlights
Summary
This trialwill examine if stimulants improve executive functioning in college students with ADHD but not those without, to better understand efficacy and prevent misuse.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Adderall may include nervousness, restlessness, difficulty sleeping, dry mouth, headache, changes in sex drive or ability; gastrointestinal issues like diarrhea or constipation; and potentially more serious heart-related issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completed the day after each experimental appointment over a period of two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed the day after each experimental appointment over a period of two weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Addiction Research Center Inventory (ARCI) for Adderall vs. Placebo
Change in Continuous Performance Test - Identical Pairs (CPT-IP) for Adderall vs. Placebo
Change in Digit Span for Adderall vs. Placebo
+4 moreSecondary outcome measures
DSM-5 ADHD Symptoms Checklist - Modified (DSM 5-M)
Depression, Anxiety, and Stress Scale-Modified (DASS-M)
Pittsburgh Sleep Quality Index-Modified (PSQI-M)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Stimulant MedicationExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of WyomingLead Sponsor
17 Previous Clinical Trials
1,397 Total Patients Enrolled
1 Trials studying Working Memory
48 Patients Enrolled for Working Memory
Cynthia M Hartung, Ph.D.Principal Investigator - University of Wyoming
University of Wyoming
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Working Memory
48 Patients Enrolled for Working Memory
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.You have had a concussion in the last 6 months, have had two or more concussions in your life, or have had a previous traumatic brain injury.You have a medical condition that makes taking stimulant medication risky for you.People without ADHD will be excluded if they have ever used stimulant drugs without a prescription.If you have ADHD and take prescription stimulant medication, you will be asked not to take it the day before and the day of any study visits. If you are not okay with not taking your medication, you will not be able to participate.You are currently taking other medications for mental health or attention-related issues, like SSRIs, SNRIs, sedatives, or Strattera.You are taking any other prescription medications that could cause problems when taken with Adderall, such as drugs for the nervous system or blood pressure, or antihistamines.You drink a lot of caffeine every day, like more than six cups of coffee or other high-caffeine drinks.You are not allowed to use nicotine products such as cigarettes, e-cigarettes, chewing tobacco, nicotine gum, or patches regularly.
Research Study Groups:
This trial has the following groups:- Group 1: Stimulant Medication
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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