Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants

• ClinicalTrials.gov Identifier: NCT03893032
• Recruitment Status: Unknown
• First Posted: March 27, 2019
• Last Update Posted: July 31, 2019
• Sponsor: United States Army Aeromedical Research Laboratory
• Information provided by (Responsible Party): Amanda Kelley, United States Army Aeromedical Research Laboratory

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cognition	Drug: Modafinil 200mg; Drug: mixed amphetamine salts; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants
• Actual Study Start Date: July 17, 2019
• Estimated Primary Completion Date: October 2019
• Estimated Study Completion Date: October 2019

Arms and Interventions

Arm	Intervention/treatment
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
Placebo Comparator: placebo; placebo	Drug: Placebo; single oral-administration placebo tablet

Outcome Measures

Primary Outcome Measures :

1. change from baseline in working memory performance [ Time Frame: 2-hours post-dosing ]
   Digit span task
2. change from baseline in selective attention performance [ Time Frame: 2-hours post-dosing ]
   Stroop test
3. change from baseline in sustained attention performance [ Time Frame: 2-hours post-dosing ]
   Rapid Visual Information Processing Task
4. change from baseline in executive function performance [ Time Frame: 2-hours post-dosing ]
   Digit symbol substitution task
5. change from baseline in marksmanship performance [ Time Frame: 2-hours post-dosing ]
   number of targets acquired on marksmanship trainer

Secondary Outcome Measures :

1. change from baseline in impulsivity [ Time Frame: 2-hours post-dosing ]
   Stop signal task - response inhibition
2. change from baseline in impulsivity [ Time Frame: 2-hours post-dosing ]
   Continuous Performance test - rapid response initiation
3. change from baseline in risk-taking behavior [ Time Frame: 2-hours post-dosing ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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).

Contacts and Locations

Contacts

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

Locations

United States, Alabama

US Army Aeromedical Research Laboratory; Recruiting

Fort Rucker, Alabama, United States, 36362

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

Sponsors and Collaborators

United States Army Aeromedical Research Laboratory

  Study Documents (Full-Text)

Documents provided by Amanda Kelley, United States Army Aeromedical Research Laboratory:

Informed Consent Form  [PDF] July 18, 2019

More Information

• Responsible Party: Amanda Kelley, Research Psychologist, United States Army Aeromedical Research Laboratory
• ClinicalTrials.gov Identifier: NCT03893032
• Other Study ID Numbers: USAARL 2018-007; IRB M-10746
• First Posted: March 27, 2019
• Last Update Posted: July 31, 2019
• Last Verified: July 2019

• 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

Additional relevant MeSH terms:

Modafinil; Amphetamine; Central Nervous System Stimulants; Physiological Effects of Drugs; Wakefulness-Promoting Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors