Healthy Volunteers Needed for Multi-Day Sleep Study! $3210

503 Robert Grant Avenue, Silver Spring MD

Description

We are currently recruiting for an important multi-day sleep study to investigate how different sleep medications impact performance. Please see more information below. ---------- STUDY TITLE: A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers”. The name of the Principal Investigator is John Hughes, M.D. LOCATION: The Walter Reed Army Institute of Research, Sleep Research Center, 503 Robert Grant Ave, Silver Spring, MD, 20910 STUDY DURATION: One screening visit, an enrollment visit, 14 days at home wearing an activity monitor, and a full-time stay in the lab consisting of five nights, four days, and two half days. For example, a Wednesday night – Monday afternoon. STUDY PURPOSE: to compare the side effects of two sleep inducing medications in healthy volunteers. The two drugs we will be comparing – zolpidem and suvorexant (commercially known as Ambien® and Belsomra®) ¬– affect the brain’s arousal systems via very different mechanisms, so we suspect that their effects may differ. In addition to comparing the actions of these drugs on sleep, we are primarily interested in observing and comparing their side effects. This study will help determine which medication would be most effective for military members requiring treatment while on active duty. You must meet ALL of the following criteria to participate:  You must be ages 18 to 39, and in good health  You must be a non-smoker (for at least one year)  English must be your first language  If female, you must not be pregnant or nursing, and use some form of contraception  You must not have a history of sleeping problems such as insomnia or sleep apnea  You must have a body mass index (BMI) below 30 (this is calculated based on your height and weight)  You must test negative for alcohol, nicotine, illegal drugs, and not take certain medications  You must not excessively consume alcohol or caffeine  Active duty and Federal employees must be on leave during participation You cannot have current or a history of the following conditions: • Heart disease • Hypertension (high blood pressure) • A current neurologic disorder or history of one (for example, seizures or epilepsy) • A recent history of hospitalization for a psychiatric disorder • Certain allergies or immune disorders • Asthma or other airway diseases • Liver disease • Kidney disease For your own safety, you must tell the person conducting your screening visit of any medical or mental health problems you now have, or had in the past, no matter how minor. If you are taking prescription medications, over-the-counter medications, or nutritional supplements you might not be eligible to participate in this study. This is a decision that is made by a study medical investigator on a case-by-case basis. However, DO NOT stop taking prescription medications in order to participate in this study without consulting your physician. You will be required to stop consuming alcohol and caffeine during certain phases. STUDY REQUIREMENTS: This study involves three parts. PART 1: A 2-3 hour screening visit to the Sleep Research Center at the Walter Reed Army Institute of Research, located in Silver Spring, Maryland. • Here you will be asked to read and sign the informed consent form, complete questionnaires, and undergo a brief physical and medical history assessment. • You will also provide urine, saliva, and blood samples to test for general health, pregnancy (if female), and prohibited substances. • You are compensated $25.00 for this part whether or not you are selected to participate in this study. PART 2: Will be scheduled if you are qualified to participate based on the initial screening. • You will report to the Sleep Research Center for a 2-3 hour visit where you will complete questionnaires and provide urine and saliva to test for prohibited substances and pregnancy. • No prescription or over-the-counter medications may be taken during the duration of the study unless previously approved by the Medical Investigator. One exception to this, for example, is that women should continue to take prescription contraceptives. • You must abstain from nicotine, caffeine and alcohol starting 48 hours prior to this phase and for the duration of your participation. • You will receive a wrist-worn activity monitor to wear continuously for 14 days, during which you will be able to maintain your typical schedule. • On the 15th day you will return to the Sleep Research Center for the third part of the study. PART 3: You will stay at the Sleep Research Center for five continuous nights, four whole days, and two partial days. • Here you will provide urine and saliva samples upon arrival to test for prohibited substances and pregnancy. • Participants will be asked to provide a stool sample using a kit we provide you. • You will complete paper and computer tests periodically during this part of the study • You will have electrodes applied to your scalp for the duration of the study • You will be asked to sleep with earphones on at night. These earphones should not interfere with sleep. At certain times tones will be played through the earphones which may or may not wake you up. These tones are at a safe volume and will not cause any damage to your ears. • You will be asked to participate in a pain threshold stressor applied through a cold water task in which you will be asked to submerge your hand in a cold water bath. • The first night you will be allowed to sleep normally throughout the night • The next day (Day 16) you will have a peripheral venous catheter, commonly called an “IV”, inserted into a superficial vein to allow for repeated blood sampling with minimal discomfort. This IV will be removed up to 18 hours after it was inserted. A second IV will be inserted on Day 18 and again removed up to 18 hours later. • Blood samples may be used for genetic testing in the future. Agreeing to the storing of blood samples is optional and is not a requirement for participation in the study. • On the nights 16, 17 and 18 you will be woken up late during the night and go on to complete a series of tests. About an hour later, you will return to bed to sleep for the remainder of the night. • On the night 17, you will receive a dose of one of two different sleep aid medications or a placebo drug. Your receipt of the study drug or placebo will be determined by the group to which you are assigned, and neither you, nor the study team will know to which group you have been assigned. You will be closely monitored for side effects. • On the night 18, you will receive another dose of one of two different sleep aid medications or a placebo drug. You will be closely monitored for side effects. • During day 19, you will complete tests throughout the day and be allowed to sleep normally throughout the night. • On day 20, you will complete a series of tests, followed by a medical examination by a study medical investigator, and then you will be released. COMPENSATION FOR PARTICIPATION: If you complete all parts of the study, you will be compensated up to $2,860.00 for successful completion of the study with a $350.00 bonus based on effort. The maximum total amount you will be paid is $3210.00 NOTE: Participation is voluntary. Even if you come in for the screening visit, you are not obligated to go through the entire screening visit or to participate in the study. You can change your mind during any phase of the study. If at any point you need to contact the study staff, please call (301) 319-9287. To learn more about this study or schedule a screening appointment, please contact the WRAIR SRC Phone: 301-319-9287 (Monday-Friday 9:00am – 5:00pm)