Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants

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.

Study Overview

• Status: Unknown
• Conditions: Cognition
• Intervention / Treatment: Drug: Modafinil 200mg; Drug: mixed amphetamine salts; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Fort Rucker, Alabama, United States, 36362
      • Recruiting
      • US Army Aeromedical Research Laboratory
      • Contact: Amanda M Kelley, PhD; Phone Number: 334-498-2456; Email: amanda.m.kelley.civ@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: Placebo; single oral-administration placebo tablet
EXPERIMENTAL: Modafinil 200mg; single, 200 mg dose of modafinil	Drug: Modafinil 200mg; single 200 mg dose
EXPERIMENTAL: mixed amphetamine salts; single 10 mg dose of mixed amphetamine salts	Drug: mixed amphetamine salts; single 10 mg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in working memory performance	Digit span task	2-hours post-dosing
change from baseline in selective attention performance	Stroop test	2-hours post-dosing
change from baseline in sustained attention performance	Rapid Visual Information Processing Task	2-hours post-dosing
change from baseline in executive function performance	Digit symbol substitution task	2-hours post-dosing
change from baseline in marksmanship performance	number of targets acquired on marksmanship trainer	2-hours post-dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in impulsivity	Stop signal task - response inhibition	2-hours post-dosing
change from baseline in impulsivity	Continuous Performance test - rapid response initiation	2-hours post-dosing
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)	2-hours post-dosing

Collaborators and Investigators

• Sponsor: United States Army Aeromedical Research Laboratory

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2019
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Wakefulness-Promoting Agents; Amphetamine; Modafinil
• Other Study ID Numbers: USAARL 2018-007; IRB M-10746

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes