Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants

NCT03893032 | Unknown Phase 2 FDA Drug

• 1 other identifier: USAARL 2018-007; IRB M-10746
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• change from baseline in impulsivity

  2-hours post-dosing

• change from baseline in impulsivity

  2-hours post-dosing

• change from baseline in risk-taking behavior

  2-hours post-dosing

Study Arms (3)

Modafinil 200mg

EXPERIMENTAL

single, 200 mg dose of modafinil

Drug: Modafinil 200mg

mixed amphetamine salts

EXPERIMENTAL

single 10 mg dose of mixed amphetamine salts

Drug: mixed amphetamine salts

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Modafinil 200mg DRUG

single 200 mg dose

Modafinil 200mg

mixed amphetamine salts DRUG

single 10 mg dose

mixed amphetamine salts

Placebo DRUG

single oral-administration placebo tablet

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• United States Army Aeromedical Research Laboratory: lead

Study Sites (1)

US Army Aeromedical Research Laboratory

Fort Rucker, Alabama, 36362, United States

RECRUITING

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Amanda M Kelley, PhD

CONTACT

334-498-2456; amanda.m.kelley.civ@mail.mil

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: July 17, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (1)