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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil 200mg | Experimental | single, 200 mg dose of modafinil |
|
| mixed amphetamine salts | Experimental | single 10 mg dose of mixed amphetamine salts |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil 200mg | Drug | single 200 mg dose |
| |
| mixed amphetamine salts |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda M Kelley, PhD | Contact | 334-498-2456 | amanda.m.kelley.civ@mail.mil |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Army Aeromedical Research Laboratory | Recruiting | Fort Rucker | Alabama | 36362 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 12, 2021 | |
| Reset | Nov 8, 2021 | |
| Release | Nov 1, 2022 | |
| Reset | Sep 8, 2023 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2019 | Jul 29, 2019 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 12, 2021 | Nov 8, 2021 | |||
| Nov 1, 2022 |
| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
single 10 mg dose |
|
| Placebo | Drug | single oral-administration placebo tablet |
|
| 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 |
| Sep 8, 2023 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |