A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Vo… (NCT04273776) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study
United States90 participantsStarted 2019-12-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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.
Exclusion Criteria
* 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 tha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
consolidation of episodic memory
Timeframe: 5 days
2
psychomotor vigilance test
Timeframe: 4 days
Trial details
NCT IDNCT04273776
SponsorWalter Reed Army Institute of Research (WRAIR)