Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag

• Status: Completed
• Trial end date: 2007-11-14
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the effects of cortisol (hydrocortisone), melatonin, a combination of cortisol and melatonin, and placebo (an inactive substance) on jet lag symptoms. Jet lag is a term used to describe symptoms people commonly experience after rapid travel across several time zones. The cause of jet lag is not known, but various hormones, including cortisol and melatonin, have a day-to-night pattern of secretion and play a role in maintaining the body's internal rhythms. This study will test whether taking cortisol, melatonin, or both can help re-establish the body's day-night cycle and result in less jet lag.

People between 18 and 65 years of age who are planning a non-stop eastward flight with the following characteristics may be eligible for this study:

• Crossing six to eight time zones (6 to 8 hours difference between Eastern Standard Time and the destination)

• Destination between 30 and 50 latitudes (approximately Cairo to London)

• Evening flight (5 PM to midnight) with morning arrival

• Remaining abroad at least 4-10 days

Candidates must have a body mass index (BMI) between 20 and 30 kg/M (not too thin and not overweight) and must not be taking medicines that affect sleep or cortisol or melatonin levels. Prospective participants are screened with a medical history, blood tests, and check of blood pressure, height, and weight.

Pre-flight Procedures

Participants keep a sleep journal 3 days before the flight. For 1 day within 3 days of the flight they fill out jet lag and sleepiness questionnaires and collect morning and bedtime saliva samples for measurement of cortisol and melatonin. The saliva is collected by chewing on two small cotton pads and spitting them into a tube. Premenopausal women provide a urine sample the week before the flight to test for pregnancy. On the day of the flight, the participants do not collect saliva or fill out sleep logs or questionnaires. They are given two bottles with study medication. One bottle, labeled "AM," contains either hydrocortisone or placebo; the other, labeled "PM," contains either melatonin or placebo.

Post-flight Procedures

Upon arriving at their destination in the morning, participants obtain a saliva sample and take one of the capsules in the "AM" bottle. At bedtime, they collect saliva and then take one of the "PM" capsules. They repeat the medication doses for a total of 4 days and repeat the saliva collections on days 2 through 4, 7 and 10 after arrival. In addition, participants complete jet lag and sleep questionnaires in the morning, afternoon, and just before bedtime on the day of arrival and on days 2 through 4, 7 and 10.

After they return from their trip, participants are seen at the NIH Clinic to bring in their saliva specimens and review their questionnaires with study investigators.

...

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Melatonin

Criteria

• INCLUSION CRITERIA:

• Age greater than or equal to 18, but less than or equal to 65, men or women.

• Normal physical exam and laboratory results.

• Negative urinary pregnancy test 1 week prior to travel (pre-menopausal women).

• Planned non-stop eastward flight crossing 6-8 time zones between 30n and 50n latitudes.

• A minimum stay of 4 - 10 days abroad.

• Willingness and anticipated ability to comply with study procedures, including sleep and wake hours, saliva collection and questionnaire completion.

• Written informed consent.

EXCLUSION CRITERIA:

• BMI less than or equal to 20 or greater than or equal to 30 kg/m.

• Current psychiatric or seizure disorder.

• Current sleep disorder as assessed by presence of sleep apnea, daytime napping of more than 20 minutes, chronic fatigue.

• History of Cushing's syndrome.

• Serious chronic medical condition.

• Current drug or alcohol abuse.

• SGOT or SGPT greater than three-fold normal.

• Current pregnancy or lactation.

• Current use of CPAP.

• Chronic use of beta-blockers (which inhibit melatonin secretion), anti-epileptic agents, anticoagulants, fluvoxamine, nifedipine or soporific or sleep-inducing agents (including benzodiazepines, melatonin), or glucocorticoids (including nasal or inhaled steroids).

• Fasting blood glucose greater than 110 mg/dL or known diabetes.