Performance Enhancing Product UseEarly Phase 1NCT04273776
A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study
A Early Phase 1 study testing Suvorexant 10 mg and Zolpidem in people with Performance Enhancing Product Use, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance Enhancing Product Use
- What is being tested?
- Suvorexant 10 mg and Zolpidem
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 12 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and non-pregnant, non-lactating female volunteers must be between the ages of 18 and 39
- learned English as a first language (inclusive)*.
- To be included in the study, volunteers will have to pass a "Volunteer Comprehension Assessment" with a score of 80% or greater. A maximum of two attempts is permitted. See section 5.7 for details.
- Females of child-bearing potential must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)
- Volunteers must have learned English as their first language. This is because there are cognitive tests administered during the study that require a mastery of the English language.
Who cannot join
- Self-reported habitual nightly sleep amounts outside the target range of approximately 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist).
- Any use of prescription or over-the-counter sleep aids during the 3-month period prior to screening determined by the examining study medical investigator to be indicative of a potential sleep disorder (e.g., use of a sleep aid for several nights following travel across multiple time zones would not necessarily constitute evidence of a sleep disorder).
- Self-reported nighttime lights-out times earlier than 2000 or later than 0100 during weeknights (Sunday through Thursday) (Post-consent Checklist)
- Self-reported morning wake-up times earlier than 0500 or later than 0900 during weekdays (Monday through Friday) (Post-consent Checklist)
- Self-reported habitual napping (> 3 times a week) in conjunction with normal sleep habits (Post-consent Checklist).
- Self-reported symptoms suggestive of a sleep disorder (including but not limited to insomnia, narcolepsy, sleep disordered breathing/sleep apnea, idiopathic hypersomnia, restless leg syndrome, parasomnias, REM behavior disorder, etc.) (Post-Consent Checklist, Medical History/Exam form; Berlin Questionnaire); history of a sleep disorder (Medical History and Examination) or evidence of such from a prior polysomnographic assessment.
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- Objective evidence of narcolepsy + cataplexy using the Ullanlinna Narcolepsy Scale
- Objective evidence of insomnia using the Insomnia Severity Index.
- STATE TRAIT ANXIETY INVENTORY - TRAIT (STAI-T) - Scores above 40.
- MORNING-EVENINGNESS QUESTIONNAIRE -Scores lower than 31 or greater than 69.
- Self-reported caffeine use in excess of 400 mg (e.g., approximately 8 caffeinated sodas or approximately 20 ounces of brewed coffee) per day on average (Post-consent Checklist)
- History of neurologic disorder (including but not limited to epilepsy or another seizure disorder, amnesia, hydrocephalus, Parkinson's disease, MS) (Medical History and Examination form). An infrequent or resolved single neurological event (e.g., childhood seizure, rare sporadic migraine headaches, resolved meningeal infection with no sequelae) may be deemed non-exclusionary at the discretion of the examining study medical investigator.
- Score of 14 or above on the Beck Depression Inventory (BDI form)
- History of cardiovascular disease (including but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of myocardial infarction) (Medical History/Exam form)
- Underlying acute or chronic pulmonary disease requiring daily inhaler use (Medical History /Exam form)
- Kidney disease or significant kidney abnormalities (Medical History/Exam form, laboratory results) as determined by examining study medical investigator.
- Liver disease or significant liver abnormalities (Medical History/Exam form, laboratory results) as determined by examining study medical investigator.
- Self-reported history of psychiatric disorder requiring hospitalization or psychiatric medication for more than 6 months (Medical History/Exam form)
- Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases, to be determined on a case-by-case basis by the examining study medical investigator (Medical History/Exam form).
- Self-reported or suspected heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week or as determined by the examining study medical investigator).
- Self-reported or suspected regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week) within the last 1 year.
- Self-reported or suspected current use of other illicit drugs (including but not limited to benzodiazepines, amphetamines, cocaine, marijuana) (Medical History/Exam form)
- Positive urine pregnancy result
- Positive salivary alcohol screening result
- Self-reported or suspected current breast-feeding or collecting breast-milk (Medical History/Exam form)
- Resting blood pressure above 140/90 or resting pulse > 110 beats per minute (Medical History/Exam form) Note that if a repeat measurement is within range, volunteer will not be excluded.
- BMI ≥ 30 (Obese Class I or greater) (Medical History/Exam form)
- Clinically significant values (as determined by the reviewing study medical investigator and the table below) for any hematology or chemistry parameter included in the screening bloodwork.
- Positive urine nicotine/cotinine result during screening visit (NicCheckTM I test strip results)
- Positive urine drug screen result
- Inability to read and sign consent
- Failure to obtain required approved official leave to participate
- Presence of features that may increase risk and/or discomfort during the cold pressor task. These include: past cramp attacks or blackouts, chilblains, open skin wounds, fracture of the hands, and skin and peripheral vascular diseases (to include but not limited to Raynaud's disease.
- As prisoners will not be recruited and are not eligible for participation in this study, any participant that becomes incarcerated during Phase 1 will result in termination from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.
- Conditions
- Performance Enhancing Product Use
- Being tested
- Suvorexant 10 mg, Zolpidem, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suvorexant 10 mgDrug
10 mg of suvorexant
ZolpidemDrug
5 mg of zolpidem
PlacebosDrug
Avicel
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant Arm | Active comparator | 10 mg of Suvorexant Receives: Drug: Suvorexant 10 mg; Drug: Placebos |
| Zolpidem Arm | Active comparator | 5 mg of Zolpidem Receives: Drug: Zolpidem; Drug: Placebos |
| Placebo | Placebo comparator | 10mg of Avicel Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
consolidation of episodic memory
presentation of word lists
Measured: 5 days
psychomotor vigilance test
measures reaction time
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Dec 2019
- Primary completion21 Nov 2024
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance Enhancing Product UseStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomization will occur at the level of the study session such that all volunteers participating in the same session will be "blocked" together (i.e., assigned the same condition).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273776
- Sponsor's protocol ID
- WRAIR #2492
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2020
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04273776
- Acronym / sponsor ID
- WRAIR #2492
- Conditions
- Performance Enhancing Product Use
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 18 Feb 2020 (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.
The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomization will occur at the level of the study session such that all volunteers participating in the same session will be "blocked" together (i.e., assigned the same condition).
| Arm | Type | Receives |
|---|---|---|
| Suvorexant Arm | Active comparator | Drug: Suvorexant 10 mg, Drug: Placebos10 mg of Suvorexant |
| Zolpidem Arm | Active comparator | Drug: Zolpidem, Drug: Placebos5 mg of Zolpidem |
| Placebo | Placebo comparator | Drug: Placebos10mg of Avicel |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males and non-pregnant, non-lactating female volunteers must be between the ages of 18 and 39
- learned English as a first language (inclusive)*.
- To be included in the study, volunteers will have to pass a "Volunteer Comprehension Assessment" with a score of 80% or greater. A maximum of two attempts is permitted. See section 5.7 for details.
- Females of child-bearing potential must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)
Key exclusion criteria (34 listed)
- Self-reported habitual nightly sleep amounts outside the target range of approximately 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist).
- Any use of prescription or over-the-counter sleep aids during the 3-month period prior to screening determined by the examining study medical investigator to be indicative of a potential sleep disorder (e.g., use of a sleep aid for several nights following travel across multiple time zones would not necessarily constitute evidence of a sleep disorder).
- Self-reported nighttime lights-out times earlier than 2000 or later than 0100 during weeknights (Sunday through Thursday) (Post-consent Checklist)
- Self-reported morning wake-up times earlier than 0500 or later than 0900 during weekdays (Monday through Friday) (Post-consent Checklist)
- Self-reported habitual napping (> 3 times a week) in conjunction with normal sleep habits (Post-consent Checklist).
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 |
|---|---|---|
| Suvorexant 10 mg10 mg of suvorexant | Drug | Suvorexant Arm |
| Zolpidem5 mg of zolpidem | Drug | Zolpidem Arm |
| PlacebosAvicel | Drug | Placebo, Suvorexant Arm, Zolpidem Arm |
Primary outcome
consolidation of episodic memory
Time frame: 5 days
presentation of word lists
psychomotor vigilance test
Time frame: 4 days
measures reaction time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Suvorexant 10 mg and Zolpidem in people with Performance Enhancing Product Use, run by Walter Reed Army Institute of Research (WRAIR) 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 5 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consolidation of episodic memory (time frame: 5 days). The study lists 2 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 3 Apr 2025.