CognitionPhase 2NCT03893032
Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants
A Phase 2 study testing Modafinil 200mg and mixed amphetamine salts in people with Cognition, run by United States Army Aeromedical Research Laboratory at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Modafinil 200mg and mixed amphetamine salts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2019to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
US Army Aeromedical Research Laboratory
Fort Rucker, Alabama, 36362
Amanda M Kelley, PhD, 334-498-2456, amanda.m.kelley.civ@mail.mil
About this study
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
- Being tested
- Modafinil 200mg, mixed amphetamine salts, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modafinil 200mgDrug
single 200 mg dose
mixed amphetamine saltsDrug
single 10 mg dose
PlaceboDrug
single oral-administration placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Modafinil 200mg | Experimental | single, 200 mg dose of modafinil Receives: Drug: Modafinil 200mg |
| mixed amphetamine salts | Experimental | single 10 mg dose of mixed amphetamine salts Receives: Drug: mixed amphetamine salts |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in working memory performance
Digit span task
Measured: 2-hours post-dosing
change from baseline in selective attention performance
Stroop test
Measured: 2-hours post-dosing
change from baseline in sustained attention performance
Rapid Visual Information Processing Task
Measured: 2-hours post-dosing
change from baseline in executive function performance
Digit symbol substitution task
Measured: 2-hours post-dosing
change from baseline in marksmanship performance
number of targets acquired on marksmanship trainer
Measured: 2-hours post-dosing
Secondary outcomes (3)
change from baseline in impulsivity
Stop signal task - response inhibition
Measured: 2-hours post-dosing
change from baseline in impulsivity
Continuous Performance test - rapid response initiation
Measured: 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)
Measured: 2-hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start17 Jul 2019
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Army Aeromedical Research Laboratory
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Amanda Kelley, United States Army Aeromedical Research Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893032
- Sponsor's protocol ID
- USAARL 2018-007; IRB M-10746
- Status last verified
- Jul 2019
- First submitted
- 25 Mar 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants
- ClinicalTrials.gov ID
- NCT03893032
- Acronym / sponsor ID
- USAARL 2018-007; IRB M-10746
- Conditions
- Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- United States Army Aeromedical Research LaboratoryUS federal agency
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modafinil 200mg | Experimental | Drug: Modafinil 200mgsingle, 200 mg dose of modafinil |
| mixed amphetamine salts | Experimental | Drug: mixed amphetamine saltssingle 10 mg dose of mixed amphetamine salts |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinil 200mgsingle 200 mg dose | Drug | Modafinil 200mg |
| mixed amphetamine saltssingle 10 mg dose | Drug | mixed amphetamine salts |
| Placebosingle oral-administration placebo tablet | Drug | placebo |
Primary outcome
change from baseline in working memory performance
Time frame: 2-hours post-dosing
Digit span task
change from baseline in selective attention performance
Time frame: 2-hours post-dosing
Stroop test
change from baseline in sustained attention performance
Time frame: 2-hours post-dosing
Rapid Visual Information Processing Task
change from baseline in executive function performance
Time frame: 2-hours post-dosing
Digit symbol substitution task
change from baseline in marksmanship performance
Time frame: 2-hours post-dosing
number of targets acquired on marksmanship trainer
3 secondary outcomes
change from baseline in impulsivity
Time frame: 2-hours post-dosing
change from baseline in impulsivity
Time frame: 2-hours post-dosing
change from baseline in risk-taking behavior
Time frame: 2-hours post-dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
Related trials for Cognition
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modafinil 200mg and mixed amphetamine salts in people with Cognition, run by United States Army Aeromedical Research Laboratory at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda M Kelley, PhD (334-498-2456, amanda.m.kelley.civ@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in working memory performance (time frame: 2-hours post-dosing). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.