Stimulant medication use in college students: comparison of appropriate users, misusers, and nonusers.
Cynthia M Hartung, Will H Canu, Carolyn S Cleveland...
https://pubmed.ncbi.nlm.nih.gov/24059834Actively Recruiting
Phase 2
Age: 18Years - 29Years
All Genders
Healthy Volunteers
ID03935646
Acute Effects of Prescription Stimulant Medication on Cognition and Mood in College Students With and Without ADHD
Led by University of Wyoming · Updated on 2024-06-10
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the immediate effects of stimulant medication on executive functioning in college students with and without ADHD. The study aims to evaluate whether stimulants improve cognitive functions such as attention and working memory for students with ADHD, while also assessing if stimulants affect those without ADHD. The goal is to provide insights to support appropriate stimulant use and help prevent misuse among college students. The study will enroll 40 college students aged 18 to 29, including 20 diagnosed with ADHD and 20 without ADHD, balanced by sex. Participants will attend a baseline appointment for eligibility confirmation and initial assessments, followed by two experimental sessions where they will receive either a stimulant medication (Adderall IR 10mg) or a placebo in a randomized order. After a 90-minute wait, participants will complete computer-based tests measuring executive functioning. Physiological monitoring and safety oversight will be provided during appointments. Participants will complete mood and sleep questionnaires the day after each experimental session. Researchers will assess changes in cognitive tests such as the Continuous Performance Test and Spatial Span, along with questionnaires on mood, sleep, and substance use. The study includes careful screening to ensure participants are at low risk for stimulant use and medical complications. The total study duration spans approximately three weeks with repeated measures to evaluate stimulant effects compared to placebo and baseline.
CONDITIONS
Brief Title
Acute Effects of Stimulant Medication in College Students With ADHD
Who Can Participate
Age: 18Years - 29Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Be currently enrolled either full time or part time as an undergraduate in a 2-year or 4-year college
- Be between the ages of 18-29
- Be a native English speaker
- ADHD Participants: Must report a prior diagnosis of ADHD and self-report five or more inattention symptoms on the DSM-5 Symptom Checklist on the pre-screener
- Healthy Participants: Must deny ever being diagnosed with ADHD and report 3 or fewer inattention symptoms and 3 or fewer hyperactivity/impulsivity symptoms on the DSM-5 ADHD Symptom Checklist in the pre-screener and be matched by age and sex with an ADHD participant
You will not qualify if you...
- Not meeting any of the stated inclusion criteria
- Having an acute or uncontrolled disease such as cardiovascular, pulmonary, neurological, endocrine, musculoskeletal, or immunological conditions
- Being non-ambulatory or relying on walking aids
- Chronic asthma or respiratory conditions requiring inhaler use during exercise
- Uncontrolled or current syncope or postural hypotension problems
- History of stroke, aneurysm, or transient ischemic attack (TIA)
- Restrictions on exercise or physical activity by a health provider
- Pregnancy, attempting to become pregnant, or currently breastfeeding
- Current use of other psychotropic drugs like SSRIs, SNRIs, or sedatives
- Diagnosed seizure disorder, high blood pressure, glaucoma, gastrointestinal hypermotility disorder, diabetes, hypoglycemia, cardiac problems, or thyroid problems
- Diagnosed bipolar disorder, psychotic disorder, sleep disorder, eating disorder, or severe substance use disorder
- Past year diagnosis of major depressive disorder, panic disorder, generalized anxiety disorder, or any substance use disorder
- Prior treatment for substance use or unwillingness to abstain from illicit or addictive drugs including marijuana during the study
- Non-prescription stimulant use for non-ADHD participants
- ADHD participants currently prescribed stimulants must abstain from medication on study days
- Current use of non-stimulant ADHD medication or other prescription drugs that may interact with Adderall
- High levels of caffeine consumption exceeding 600mg per day
- Use of over-the-counter substances that may interact with Adderall unless abstained from 12 hours prior to visits
- Current nicotine use including cigarettes, vaping, smokeless tobacco, nicotine gum, or patches
- Concussion within the past 6 months, history of two or more concussions, or traumatic brain injury
- Unwillingness to ingest prescription stimulant medication or placebo during the study visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to confirm eligibility including health screening and baseline measures
Treatment
Duration - Up to 3 weeks
Participants attend two experimental appointments where they receive either a stimulant medication (Adderall IR 10mg) or a placebo in a counterbalanced order. During these appointments, participants complete cognitive tests after medication administration and are monitored for physiological responses.
2 in-person visits (experimental appointments) scheduled on the same day of the week and time of day
Follow-up
Duration - 2 weeks
Participants complete mood and sleep questionnaires the morning after each experimental appointment to monitor effects.
Questionnaires completed the day after each experimental appointment
Trial Site Locations
Total: 1 location
1
University of Wyoming
Laramie, Wyoming, United States, 82071
Actively Recruiting
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Research Team
C
Cynthia M Hartung, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in college students with ADHD.
George J Dupaul, Lisa L Weyandt, Joseph S Rossi...
https://pubmed.ncbi.nlm.nih.gov/22166471