Acute Effects of Stimulant Medication in College Students With ADHD

NCT03935646 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 20190124JV02251
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will examine the acute effects of stimulant medication on executive functioning. The rationale for the proposed study is to examine the efficacy of stimulants for college students with ADHD and help prevent stimulant misuse among college students without ADHD. The working hypothesis is that stimulants, compared to baseline and placebo conditions, will improve executive functioning for college students with ADHD but not for college students without ADHD. Improvements on executive functioning measures (e.g., CPT-IP, Spatial Span) will be examined through 2 (ADHD vs. non-ADHD) x 3 (Baseline, Placebo, Stimulant) repeated measures ANOVAs. Follow-up analyses will include paired comparisons. Expected outcomes are to confirm these hypotheses and demonstrate the need for further study of stimulants. If confirmed, the results will provide pilot data for a larger NIH grant proposal aimed at further examining the acute effects of stimulants (i.e., improved cognitive functioning with stimulants) and comparing them to the acute effects of physical exercise (i.e., improved cognitive functioning immediately after exercise). The investigators expect this outcome to have an important positive impact because it can help support stimulant medication as an effective treatment for college students with ADHD (DuPaul et al., 2012). Additionally, demonstration that stimulants do not improve executive functioning for college students without ADHD can be used to help prevent and discourage stimulant misuse and diversion on college campuses (Hartung et al., 2013).

Conditions

Attention Deficit Hyperactivity Disorder; Stimulant Use; Working Memory; Change in Sustained Attention; Mood

Keywords

Attention Deficit Hyperactivity Disorder; Stimulant Use; Working Memory; Change in Sustained Attention; Mood

Outcome Measures

Primary Outcomes (7)

• Change in Continuous Performance Test - Identical Pairs (CPT-IP) for Adderall vs. Placebo

  The CPT-IP is a standardized computer-administered test consisting of four-digit numbers that are presented for 200ms on a white screen with 1500ms between the presentation of each number. Participants must press the spacebar as quickly as possible when the preceding four-digit number matches the current four-digit number. Participants will complete the CPT-IP as a measure of sustained attention at baseline and at each experimental appointment.

  Completed at baseline and each experimental appointment over a period of three weeks

• Change in Spatial Span (SS) for Adderall vs. Placebo

  The Spatial Span (SS) is a computer-administered task assessing visuospatial working memory. Participants will be tasked with remembering the order of stimuli that are presented in forward and backward sequences. Participants will complete the SS visuospatial working memory task at baseline and at each experimental appointment.

  Completed at baseline and each experimental appointment over a period of three weeks

• Change in Digit Span for Adderall vs. Placebo

  The Digit Span (Wechsler, 2008) subtest of the Wechsler Adult Intelligence Scale (WAIS-IV) is an auditory working memory task. The researcher will say numbers aloud at a rate of one number per second. The participant will be tasked with remembering and repeating the numbers in a prescribed (forward, backward, sequencing) order. Participants will complete the Digit Span (forward, backward and sequencing) auditory working memory task at baseline and at each experimental appointment.

  Completed at baseline and each experimental appointment over a period of three weeks

• Change in Letter-Number Sequencing for Adderall vs. Placebo

  The Letter-Number Sequencing (Wechsler, 2008) task is a supplemental subtest of the Wechsler Adult Intelligence Scale (WAIS-IV) that measures auditory working memory. Researchers will read a sequence of letters and numbers, and the participant will attempt to recall the numbers in ascending order and the letters in alphabetical order. Participants will complete the Letter-Number Sequencing auditory working memory task at baseline and at each experimental appointment.

  Completed at baseline and each experimental appointment over a period of three weeks

• Visual Analogue Scales (VAS) for Adderall vs. Placebo

  The VAS is a nine-item questionnaire that assesses subjective mood in the moment including how good, bad, focused, and motivated participants feel. Additionally, participants are asked how well they expect to perform on cognitive tests and how much effort they will put into completing cognitive tests. Participants will complete the VAS at each experimental appointment.

  two weeks

• Addiction Research Center Inventory (ARCI) for Adderall vs. Placebo

  The ARCI is a 49 true-false item measure that assesses drug effects by asking how the participant feels in the moment. Participants will complete the ARCI at each experimental appointment.

  two weeks

• Intentions to Use Questionnaire (IUQ) for Adderall vs. Placebo

  The IUQ is a six-item measure that assesses the likelihood of participants to use substances including prescription stimulants for specific purposes such as for studying or improving academic performance. Participants will complete the IUQ at each experimental appointment.

  two weeks

Secondary Outcomes (5)

• Pittsburgh Sleep Quality Index-Modified (PSQI-M)

  Completed the day after each experimental appointment over a period of two weeks

• Depression, Anxiety, and Stress Scale-Modified (DASS-M)

  Completed the day after each experimental appointment over a period of two weeks

• DSM-5 ADHD Symptoms Checklist - Modified (DSM 5-M)

  Completed the day after each experimental appointment over a period of two weeks

• Side Effects Rating Scale - Modified

  Completed the day after each experimental appointment over a period of two weeks

• Substance Use Day After Questionnaire

  Completed the day after each experimental appointment over a period of two weeks

Study Arms (1)

Stimulant Medication

EXPERIMENTAL

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.

Drug: Adderall IR 10mg; Drug: Placebo

Interventions

Adderall IR 10mg DRUG

At one of the experimental appointments, participants will be administered a stimulant medication. Following a wait period, the participants will complete executive functioning tasks of working memory and sustained attention.

Also known as: Stimulant Medication Manipulation

Stimulant Medication

Placebo DRUG

Placebo

Stimulant Medication

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 (IA) symptoms on the DSM-5 Symptom Checklist on the pre-screener.
• Healthy Participants: Must disavow ever being diagnosed with ADHD, report 3 or fewer IA symptoms and 3 or fewer hyperactivity/impulsivity (HI) symptoms on the DSM-5 ADHD Symptom Checklist in the pre-screener and are an age and sex match of an ADHD group participant

You may not qualify if:

• Any contraindications for physical exercise placing the participant at moderate or high-risk. This includes the following:
• Participants will be excluded if they report having an acute or uncontrolled disease (cardiovascular, pulmonary, neurological, endocrine, musculoskeletal, immunological).
• Participants will be excluded if they are non-ambulatory or rely on walking aids for ambulation.
• Participants will be excluded who chronically manage asthma or another respiratory condition or require using an inhaler to complete exercise.
• Participants will be excluded if they experience uncontrolled or current problems with syncope (loss of consciousness or fainting) or postural hypotension.
• Participants will be excluded if they have ever had a stroke, aneurysm, or transient ischemic attack (TIA).
• Participants will be excluded if they have exercise or physical activity restrictions imposed by a health provider.
• Participants will be excluded by the medical director due to possible underlying disease/condition or risk.
• Participants will be excluded if they are pregnant (determined by a urine pregnancy test), are attempting to become pregnant, or are currently breastfeeding will also be excluded (stated above).
• Participants will be excluded for any current use of other psychotropic drugs (e.g., SSRIs, SNRIs, sedatives; stated above).
• Any contraindications for stimulant medication use placing the participant at moderate or high-risk. This includes the following:
• Participants will be excluded if they have ever been diagnosed with seizure disorder, high blood pressure, glaucoma, gastrointestinal hypermotility disorder (e.g., IBS), diabetes, hypoglycemia, cardiac problems (e.g., heart disease), or thyroid problems.
• Participants will be excluded if they have ever been diagnosed with a bipolar disorder (e.g., Bipolar I or Bipolar II), a psychotic disorder (e.g., schizophrenia), a sleep disorder (e.g., narcolepsy), an eating disorder (e.g., bulimia nervosa), or a severe substance use disorder (e.g., endorsing six or more symptoms of a substance use disorder according to the DSM-5). Participants will also be excluded if they report a past year diagnosis of major depressive disorder, panic disorder, generalized anxiety disorder, or any substance use disorder.
• Participants will be excluded if they report any prior treatment for substance use (e.g. rehabilitation for alcohol or other substance use). Additionally, participants will be excluded if they do not agree to abstain from illicit or addictive drugs and marijuana use for the duration of the study beginning with the eligibility assessment.
• Participants will be excluded if they experience uncontrolled or current problems with syncope (e.g., loss of consciousness or fainting) or postural hypotension.

Sponsors & Collaborators

• University of Wyoming: lead

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82071, United States

RECRUITING

Related Publications (2)

• Hartung CM, Canu WH, Cleveland CS, Lefler EK, Mignogna MJ, Fedele DA, Correia CJ, Leffingwell TR, Clapp JD. Stimulant medication use in college students: comparison of appropriate users, misusers, and nonusers. Psychol Addict Behav. 2013 Sep;27(3):832-40. doi: 10.1037/a0033822.

  PMID: 24059834 BACKGROUND

• Dupaul GJ, Weyandt LL, Rossi JS, Vilardo BA, O'Dell SM, Carson KM, Verdi G, Swentosky A. Double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in college students with ADHD. J Atten Disord. 2012 Apr;16(3):202-20. doi: 10.1177/1087054711427299. Epub 2011 Dec 12.

  PMID: 22166471 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Cynthia M Hartung, Ph.D.

  University of Wyoming

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia M Hartung, Ph.D.

CONTACT

307-314-2123; chartung@uwyo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a mixed (within-subjects and between-subjects) design. ADHD and comparison participants will complete outcome measures at baseline and at two counter-balanced experimental sessions (placebo, Adderall).

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: February 11, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)