Clinical trial: Acute Effects of Stimulant Medication in College Students With ADHD (NCT03935646)

Eligibility criteria:
Inclusion Criteria:

          -  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 18-30

          -  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

        Exclusion Criteria:

          -  Not meeting any of the above stated inclusion criteria

          -  Any contraindications for physical exercise placing the participant at moderate or
             high-risk. This includes the following:

               1. Participants will be excluded if they report having an acute or uncontrolled
                  disease (cardiovascular, pulmonary, neurological, endocrine, musculoskeletal,
                  immunological).

               2. Participants will be excluded if they are non-ambulatory or rely on walking aids
                  for ambulation.

               3. Participants will be excluded who chronically manage asthma or another
                  respiratory condition or require using an inhaler to complete exercise.

               4. Participants will be excluded if they experience uncontrolled or current problems
                  with syncope (loss of consciousness or fainting) or postural hypotension.

               5. Participants will be excluded if they have ever had a stroke, aneurysm, or
                  transient ischemic attack (TIA).

               6. Participants will be excluded if they have exercise or physical activity
                  restrictions imposed by a health provider.

               7. Participants will be excluded by the medical director due to possible underlying
                  disease/condition or risk.

               8. 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).

               9. 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:

               1. 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.

               2. 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.

               3. 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.

               4. Participants will be excluded if they experience uncontrolled or current problems
                  with syncope (e.g., loss of consciousness or fainting) or postural hypotension.

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

               6. Non-ADHD participants will be excluded if they have ever engaged in
                  non-prescription stimulant use.

               7. ADHD participants who are currently prescribed a prescription stimulant will be
                  asked not to take their medication the day prior to and day of any study visits.
                  They will be excluded if they are not comfortable with abstaining.

               8. Participants will be excluded for any current use of other psychotropic drugs
                  (e.g., SSRIs, SNRIs, sedatives) or non-stimulant ADHD medication (i.e.,
                  Strattera).

               9. Participants will be excluded for any current use of any other prescription
                  medication that could interact negatively with Adderall (e.g., neurological and
                  blood-pressure drugs, antihistamines).

              10. They will also be excluded for current use of high levels of caffeine consumption
                  (e.g., daily use more than 600mg/day or about six 8-oz. cups of coffee). Daily
                  use is defined as 5 or more days per week for the last month.

              11. Participants who are using other over-the-counter-substances that could interact
                  negatively with Adderall (e.g., dietary supplements, weight-loss pills, and
                  low-to-moderate levels of caffeine consumption, antihistamines) will be asked to
                  abstain from use for at least 12-hours prior to lab visits. They will be excluded
                  if they are not comfortable with abstaining.

              12. Participants will be excluded if they report current nicotine use (i.e., 5 or
                  more cigarettes per day), daily vaping (i.e., e-cigarettes), smokeless tobacco
                  (i.e., chewing tobacco), nicotine gum, and/or nicotine patches use in the past
                  month.

              13. Participants will be excluded if they experienced a concussion within the past 6
                  months, have experienced two or more concussions in their lifetime, or have a
                  history of traumatic brain injury.

              14. Participants will be excluded if they have ever had a stroke, aneurysm, or
                  transient ischemic attack (TIA).

              15. Participants will be excluded if they are unwilling to ingest a prescription
                  stimulant medication (Adderall) or placebo in the lab.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment