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Status unknownNCT03893032Updated Jul 31, 2019

Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants

A Phase 2 interventional study of Modafinil 200mg and mixed amphetamine salts in Cognition, sponsored by United States Army Aeromedical Research Laboratory. Status unknown at 1 site in United States. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-31.

Sponsored by United States Army Aeromedical Research Laboratory · Phase 2, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
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Study summary

Considerable research has documented the optimization utility of stimulants in sleep deprived Soldiers and aviators, however, the research for enhancement purposes has demonstrated mixed results. One significant factor that may influence enhancement properties is general intelligence such that low performers exhibit stronger enhancement effects than high performers. The objective of this study is to determine whether stimulants (specifically, modafinil and Adderall) can enhance Soldier cognitive abilities and performance on military tasks. To do so, a within-subjects design will be employed using healthy, rested Soldiers and measuring performance on a set of basic cognitive assessments and operationally relevant tasks.

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Conditions studied

  • Cognition
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In context

Lead sponsor

United States Army Aeromedical Research Laboratory is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Must be at least 18 years old.
  • Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report
  • Must have obtained at minimum 6 hours of sleep prior to all testing sessions, as assessed by actigraphy data and self-report. Should the actiwatch malfunction, reliance on self-report will suffice. If the subject does not meet this requirement, he will be asked to reschedule
  • Must have refrained from consumption of stimulants (including caffeine) and over the counter medications which may induce drowsiness for a minimum of 16 hours prior to each test session, and nicotine, 8 hours, prior to all testing sessions, assessed by self-report.

Exclusion criteria

Exclusion Criteria:

  • Currently taking medications which induce drowsiness, such as over-the-counter antihistamines. Any self-medication will be assessed through self-report.
  • No current medical conditions or medications affecting cognitive function or attention as determined by screening by study physician or medical practitioner
  • Current or recent use (as determined by study physician or medical practitioner) of medications that may interact with the test articles. Determined by self-report and exclusion at the discretion of the study physician or medical practitioner.
  • Any history of any attention deficit condition requiring medication. A history of any attention deficit condition with medication is disqualifying as the potential interactions with testing are unknown and would therefore produce a potential source of confounding or bias into the results of the study.
  • Any history of psychological/psychiatric disorder.
  • Any history of addiction or substance abuse as assessed through self-report.
  • Any history of metabolic disorder such as dysthyriodism.
  • Any history of significant cardiovascular disease or hypertension.
  • Any history of hepatic or renal disorder.
  • Females will be excluded given that the drugs administered could potentially negatively impact the very early stages of pregnancy.
  • Any ingestion of substances that may interact with the test articles or potentially skew the results within the last 16 hours prior to testing including over-the-counter medications, supplements, etc. (see attached list to be reviewed with subject).
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Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Modafinil 200mg

    single, 200 mg dose of modafinil

    Drug: Modafinil 200mg

  • Experimental
    mixed amphetamine salts

    single 10 mg dose of mixed amphetamine salts

    Drug: mixed amphetamine salts

  • Placebo comparator
    placebo

    placebo

    Drug: Placebo

Interventions

  • DrugModafinil 200mg

    single 200 mg dose

  • Drugmixed amphetamine salts

    single 10 mg dose

  • DrugPlacebo

    single oral-administration placebo tablet

06

What researchers measure

Primary outcomes

  1. change from baseline in working memory performance

    Digit span task

    Time frame: 2-hours post-dosing

  2. change from baseline in selective attention performance

    Stroop test

    Time frame: 2-hours post-dosing

  3. change from baseline in sustained attention performance

    Rapid Visual Information Processing Task

    Time frame: 2-hours post-dosing

  4. change from baseline in executive function performance

    Digit symbol substitution task

    Time frame: 2-hours post-dosing

  5. change from baseline in marksmanship performance

    number of targets acquired on marksmanship trainer

    Time frame: 2-hours post-dosing

Secondary outcomes

  1. change from baseline in impulsivity

    Stop signal task - response inhibition

    Time frame: 2-hours post-dosing

  2. change from baseline in impulsivity

    Continuous Performance test - rapid response initiation

    Time frame: 2-hours post-dosing

  3. change from baseline in risk-taking behavior

    Evaluation of Risks Scale; measures individual variability in risk assessment; three scores are produced ("need for control", "self-confidence", "risk/thrill seeking"), all scores range from 0 to 100 with higher scores indicating a higher degree of the construct (e.g., higher risk/thrill seeking scores indicate a greater degree of risk/thrill seeking)

    Time frame: 2-hours post-dosing

07

Study locations

1 of 1 sites recruiting
  • US Army Aeromedical Research Laboratory
    Fort Rucker, Alabama 36362, United States
    Recruiting
08

References and documents

Study documents

  • Informed consent form · Jul 18, 2019

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03893032
Lead sponsor
United States Army Aeromedical Research Laboratory
Responsible party
Amanda Kelley (Research Psychologist, United States Army Aeromedical Research Laboratory) — Principal investigator
First posted
Mar 27, 2019
Start date
Jul 17, 2019
Primary completion
Oct 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Jul 31, 2019

Study contacts

Amanda M Kelley, PhD
Contact
amanda.m.kelley.civ@mail.mil
334-498-2456

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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