Can a wakefulness drug keep cold, tired troops sharp?
NCT ID NCT07830056
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether modafinil helps military personnel stay alert and maintain body heat when they are sleep-deprived and exposed to cold. The trial enrolls 33 healthy adults, mostly active-duty service members, who take either modafinil or a placebo. Participants complete thinking, dexterity, and physical tests while cold and tired, and researchers track their core and skin temperatures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- modafinil, a prescription stimulant that promotes wakefulness
- What this could lead to
- If modafinil helps, it could give military personnel a way to stay sharp and maintain body heat during cold, sleepless operations.
- What could go wrong
- The trial is small, with 33 volunteers, and tests short-term effects in a controlled setting. Modafinil can cause side effects like headaches, nausea, and anxiety, and it may not work the same way in real-world conditions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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17 to 39 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy, men and women aged 18-39 years old. Active-duty military personnel who are 17 years of age will also be allowed to participate. * Willing to refrain from the use of caffeine - including dietary supplements that contain caffeine - alcohol, and nicotine 24 hours prior to data collection. * Willing to refrain from vigorous physical activity 24 hours prior to data collection. * Willing to refrain from any dietary supplement use within one week of initial screening and at any time while enrolled in the study (except a multi-vitamin containing up to 100% RDA). * Willing to consume study diets throughout the course of the study. * Supervisory approval for participation if permanent party military or a federal employee. Exclusion Criteria: * Use of modafinil or armodafinil in the last 3 months. * Known allergy to modafinil or armomodafinil. * Current medical profile, or condition, that limits, compromises, or is likely to render inconsistent performance with Grip Strength, Finger Tapping, or cardiovascular exercise on an exercise bike. * a. Individuals taking substances that directly interact with modafinil, alertness/attention/concentration, or sympathetic tone: stimulants; decongestants, barbiturates, bronchodilators; SNRIs; opioids; appetite suppressants; anti-obesity medications; b. Individuals taking substances which inhibit CYP3A4 (penicillins; macrolide antibiotics; fluoroquinolones; lomitapide; goldenseal) or MAO inhibitors. c. Individuals taking substances which induce CYP3A4 (carbamazepine, phenobarbital, rifampin) to a greater than minimal degree: systemic steroids; anti-gout agents (Exceptions can be recommended to PI for CYP3A4 inducers which do not fall into other listed categories). d. Individuals taking substances which are metabolized by CYP450 enzymes 1A2, 2B6, 2C19, or 3A4: immune-suppressant/-modulatory drugs; SSRIs; TCAs; anti-coagulants; antituberculosis agents; antimalarials; antineoplastic agents; antibody-derived drugs; antivirals; azole antifungals; anti-parasitic agents; abortive migraine medications; muscle relaxants; sex hormones or modulators; ibrexafungerp; lefamulin; palovarotene; propranolol. * Females who are pregnant or breastfeeding, have a positive- pregnancy test, or plan on becoming pregnant in the next 3 months. * Individuals currently taking/using contraceptives (i.e., oral contraceptive pill, intrauterine device, contraceptive implant, contraceptive injection, etc.) other than condoms. * Current or history of mental health issues, illness, or condition (i.e., attention deficit hyperactivity disorder, autism spectrum disorder, diagnosed depression or anxiety disorders) that OMSO physician/healthcare provider believes puts the volunteers at increased risk. * Current or history of psychosis, or history of suicidal or homicidal ideations within the past 2 years. * History of cold injuries or cold-induced asthma. * Raynaud's syndrome. * Previous hand/finger injuries that impair dexterity and hand function. * Metal hardware (plates/screws) in the upper extremities (arm/hands). * Abnormal blood count (For example: hemoglobin (Hb) outside of the typical normal values reported by LabCorp in accordance with OMSO (Normal \[Hb\] Males = 12.6-17.7 g/dL; Females = 11.1-15.9 g/dL) or hematocrit (Hct) outside of the normal ranges (Normal Hct Males = 37.5-51.0%; Females = 34.0-46.6%) levels, presence of abnormal blood laboratory measures (e.g., hemoglobin S or sickle cell traits). * Current or history of alcohol abuse (defined as Harmful Use by the World Health Organization), those who meet criteria for alcohol abuse disorder (as outlined in the DSM-5), or other substance abuse (i.e., the use of illegal drugs or the use of prescription or over-the-counter drugs for purposes other than those for which they are meant to be used, or in excessive amounts). * Diagnosed sleep disorders (i.e., sleep-apnea, narcolepsy, etc.). * Diseases and disorders of the metabolic, cardiovascular, endocrine, neurological, or gastrointestinal systems that in determination of OMSO are expected to interfere with safe conduct of the study. * A medical diagnosis of high blood pressure (hypertension). * Heart problems or prior heart attack. * Regular daily use of medication that may significantly interfere with the study drug or outcomes, as determined by the OMSO physician/healthcare provider. * Known allergies to medical adhesives. * Difficulty swallowing large pills (self-reported) for those individuals unwilling to utilize the rectal suppository of the telemetric pill. * History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis, or previous gastrointestinal surgery, etc. that OMSO physician/healthcare provider believes puts the volunteers at increased risk. * Donated blood within 8 weeks prior to study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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US Army Research Institute of Environmental Medicine
RECRUITINGNatick, Massachusetts, 01760, United States
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