Recruiting

Modafinil

Sponsor:

United States Army Research Institute of Environmental Medicine

Code:

NCT07830056

Conditions

Sleep Deprivation

Cold Exposure

Eligibility Criteria

Sex: All

Age: 17 - 39

Healthy Volunteers: Accepted

Interventions

Modafinil (M)

200 mg Microcrystalline Cellulose

Study Details

Brief summary:

Environmental and workplace stressors are common and often unavoidable in military operations. Two critical stressors are cold stress and sleep loss. They both can substantially degrade operational effectiveness. Various countermeasures are available to mitigate the adverse effects of these stressors, but due to operational requirements many are of limited use in the field. Modafinil is a drug that mitigates the effects of sleep deprivation and potentially cold stress, and modafinil may prevent performance degradation due to the combination of these stressors. This study will help determine if modafinil alters body-heat production and prevents cognitive and physical performance degradation due to cold stress in rested and sleep-deprived volunteers.

Conditions

Sleep Deprivation

Cold Exposure

Study ID

NCT07830056

Start date

Feb 18, 2025

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17 - 39

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

200 mg Microcrystalline Cellulose

active comparator: Modafinil

200 mg Modafinil

Interventions

Modafinil (M)

Evaluating the effect of Modafinil under both sleep deprivation and acute cold exposure on thermoregulation, cognitive flexibility/performance, and dexterity.

200 mg Microcrystalline Cellulose

Placebo intervention to compare to modafinil intervention.

Primary outcome measure

  • Height (in) [ Time Frame: Familiarization 1 (Day -2) ]
  • Body Weight (kg) [ Time Frame: Familiarization 1 (Day -2) ]
  • Body Composition: DXA Fat Mass (lbs) [ Time Frame: Familiarization 1 (Day -2) ]
  • Body Composition: DXA Lean Mass (lbs) [ Time Frame: Familiarization 1 (Day -2) ]
  • Body Composition: DXA Bone Mineral Content (lbs) [ Time Frame: Familiarization 1 (Day -2) ]
  • Sleep & Physical Activity [ Time Frame: Familiarization 1 to Study Completion (11 Days) ]
  • Cold Exposure: Core Temperature [ Time Frame: Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Cold Exposure: Skin Temperature [ Time Frame: Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Dexterity: Finger Tapping Task (FTT) [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Cognitive Assessment: Scanning Visual Vigilance [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Cognitive Assessment: Psychomotor Vigilance Test (PVT) [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Cognitive Assessment: Matching to Sample [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Cognitive Assessment: Grammatical Reasoning [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Cognitive Assessment: Go/No-Go Task [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Cognitive Assessment: N-Back Task [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Cognitive Assessment: Task-Switching Task [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]
  • Physical Performance: Grip Strength [ Time Frame: Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7) ]

Central Contacts and Locations

Central contacts

Locations

US Army Research Institute of Environmental Medicine

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

Principal Investigator:

Harris R Lieberman, PhD

More Information

Sponsor

United States Army Research Institute of Environmental Medicine

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • Modafinil
  • sleep deprivation
  • cold stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by United States Army Research Institute of Environmental Medicine on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.