Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03893032
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda Kelley, United States Army Aeromedical Research Laboratory

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

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893032


Contacts
Layout table for location contacts
Contact: Amanda M Kelley, PhD 334-498-2456 amanda.m.kelley.civ@mail.mil

Locations
Layout table for location information
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


Layout table for additonal information
Responsible Party: Amanda Kelley, Research Psychologist, United States Army Aeromedical Research Laboratory
ClinicalTrials.gov Identifier: NCT03893032     History of Changes
Other Study ID Numbers: USAARL 2018-007; IRB M-10746
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

Layout table for additional information
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:
Layout table for 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