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Dual Orexin Receptor Antagonist
Sleep Medications for Healthy Volunteers
Phase < 1
Waitlist Available
Research Sponsored by Walter Reed Army Institute of Research (WRAIR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy males and non-pregnant, non-lactating female volunteers must be between the ages of 18 and 39
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
Study Summary
This trial is testing two different drugs to see which induces sleep with the least side effects.
Who is the study for?
Healthy English-speaking adults aged 18-39 can join this trial. Women must use birth control if sexually active. Excluded are those with irregular sleep schedules, depression, kidney/liver disease, heavy alcohol/drug use, certain medical conditions or extreme morning/evening preferences.Check my eligibility
What is being tested?
The study tests Suvorexant (10 mg) and Zolpidem against a placebo to see which is better for sleep induction without affecting performance. It's randomized and double-blind, meaning participants and researchers don't know who gets which treatment.See study design
What are the potential side effects?
Suvorexant may cause drowsiness or dizziness the next day; Zolpidem might also affect alertness and coordination after waking up. Both drugs could potentially impact memory or mood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult between 18 and 39 years old and not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
consolidation of episodic memory
psychomotor vigilance test
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Zolpidem ArmActive Control2 Interventions
5 mg of Zolpidem
Group II: Suvorexant ArmActive Control2 Interventions
10 mg of Suvorexant
Group III: PlaceboPlacebo Group1 Intervention
10mg of Avicel
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Who is running the clinical trial?
Walter Reed Army Institute of Research (WRAIR)Lead Sponsor
107 Previous Clinical Trials
36,680 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver disease or significant liver problems.I use drugs or products that I can't stop during the study.Your score on the morning-eveningness questionnaire is either too low (below 31) or too high (above 69).I have been diagnosed with narcolepsy and cataplexy.I have been hospitalized or on psychiatric medication for over 6 months due to a mental health condition.I have kidney disease or significant kidney problems.I've used sleep aids in the last 3 months that may indicate a sleep disorder.I usually take naps more than three times a week but have normal sleep patterns.I am using birth control.I have a history of a neurological disorder.You drink a lot of alcohol or have a history of heavy alcohol consumption.You are currently using illegal drugs or suspect that you are using them.You have certain characteristics that could make the cold pressor task more risky or uncomfortable for you.I am a healthy adult between 18 and 39 years old and not pregnant or breastfeeding.My BMI is 30 or higher, classifying me as obese.You have been using nicotine regularly or suspect that you have been using it within the past year.You typically sleep less than 6 hours or more than 9 hours every night.I have a history of heart disease.You consume more than 400 mg of caffeine per day on average.I believe I have symptoms of a sleep disorder.I use an inhaler daily for my lung condition.
Research Study Groups:
This trial has the following groups:- Group 1: Zolpidem Arm
- Group 2: Placebo
- Group 3: Suvorexant Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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