Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants

July 29, 2019 updated by: Amanda Kelley, United States Army Aeromedical Research Laboratory
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Fort Rucker, Alabama, United States, 36362
        • Recruiting
        • US Army Aeromedical Research Laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change from baseline in working memory performance
Time Frame: 2-hours post-dosing
Digit span task
2-hours post-dosing
change from baseline in selective attention performance
Time Frame: 2-hours post-dosing
Stroop test
2-hours post-dosing
change from baseline in sustained attention performance
Time Frame: 2-hours post-dosing
Rapid Visual Information Processing Task
2-hours post-dosing
change from baseline in executive function performance
Time Frame: 2-hours post-dosing
Digit symbol substitution task
2-hours post-dosing
change from baseline in marksmanship performance
Time Frame: 2-hours post-dosing
number of targets acquired on marksmanship trainer
2-hours post-dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in impulsivity
Time Frame: 2-hours post-dosing
Stop signal task - response inhibition
2-hours post-dosing
change from baseline in impulsivity
Time Frame: 2-hours post-dosing
Continuous Performance test - rapid response initiation
2-hours post-dosing
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)
2-hours post-dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United States Army Aeromedical Research Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings